does anyone knows energist and their IPL device called ultra VPL?
Variable Pulsed Light (VPL) was cleared by FDA last year for hair removal. Below is a press release and text from the FDA clearance.
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Energist Secures US$17 Million Agreement with Major Asian Distributor for Light Energy-Based Products in Dermatological Applications
London, 22 December
Distributed by PR Newswire on behalf of Energist Ltd
SWANSEA, Wales, December 22 /PRNewswire/ –
- With picture
Energist Ltd., a medical technology company developing light energy-based dermatological products, today announced that it has secured a US$17 million agreement with a large Asian distributor for the ENERGIST ULTRA™ System. Energist has pioneered innovative products, most recently the advanced ENERGIST ULTRA™ system, that apply intense and variable pulsed light (VPL™) energy to treat a broad spectrum of dermatological conditions, including rosacea, pigment changes, scars, blemishes, sun damage, hair epilation and vein treatment.
“We believe our new generation product, the ENERGIST ULTRA™ System, offers the world’s most advanced light-based treatment for a variety of dermatological conditions. The product is a safe, effective and less expensive alternative to currently available products, particularly those based on laser technology,” stated Dr. Dennis Briaris, co-Founder and Director of Energist. “This distribution agreement builds on the success we have achieved to date in Asia, the world’s largest market for these products. Continued expansion into many other world markets, including the US, is already underway. The first step in selling into the US has been achieved with the imminent filing for 510K clearance with the FDA for the ENERGIST ULTRA™ System.”
Expansion into the US market and consolidating its existing Asian distribution network has been aided by Merlin Biosc
iences, which has a significant investment in Energist. With Merlin’s assistance, Energist has built a strong marketing group, completed the appointment of additional senior management and expanded on its history of solid product orders. Merlin has helped facilitate this global strategy and provide Energist with some key industry contacts.
Commenting on today’s announcement, Sir Christopher Evans, Chairman of Merlin Biosciences and also now Chairman of Energist noted: “Merlin was attracted to Energist because the Company has developed an innovative product base for which we see substantial growth not only in the treatment of skin complaints but possibly, in the future, other medical applications for which drug therapy is currently used. In the short time since inception, the Company has achieved significant product sales, and recorded profit and positive cash flow, making Energist one of the UK’s fastest growing companies.”
The potential of VPL™ in therapeutic dermatological applications is continuously being explored and expanded. Energist is sponsoring research being conducted at the University of Vienna, School of Dermatology under the auspices of a world leading authority, Prof. Robert Knobler, MD, who commented: “Variable pulsed light is probably one of the most exciting developments that I have seen and provided that enough investment is made into research, we will see the opportunity for further major treatment improvements. The use of variable pulsed light as developed by Energist in the ENERGIST ULTRA™ System has significant potential in a wide range of dermatological conditions.”
Notes to Editors:
Variable pulsed light (VPL™) is a light energy source incorporated into products driving the next generation of specialist dermatological treatments. Traditionally, these procedures have been associated with lasers but as technology has progressed, research has shown that pulsed light, and in particular variable pulsed light (VPL™) based products, are regularly producing better results than those using laser. Pulsed light systems are non-laser, emitting light across a broad range of wavelengths that are preferentially absorbed by the appropriate structures in the skin.
Energist is a research, design and manufacturing company specialising in the application of light energy for the treatment of a variety of specialist dermatological conditions. The Company’s introduction of variable pulsed light (VPL™) technology has expanded the applicability, effectiveness and safety of Energist’s products as demonstrated in numerous patient treatments. The Company has a highly successful track record and is again transforming the industry with the ENERGIST ULTRA™ System, designed to provide the power and flexibility to meet the clinical needs of dermatologists. Founded in 1999 by Dr. Dennis Briaris and Simon George, Energist is located in a new, state of the art manufacturing, design and development facility in Swansea’s Enterprise Park South Wales, UK.
Merlin Biosciences Limited is a specialised venture investor in life sciences companies. It makes equity investments on behalf of its investment partnerships. Since 1997, Merlin has invested in 27 European biotechnology companies. It is raising its third investment partnership, the Merlin Biosciences Fund III, L.P., and advises funds with EUR400 million of equity capital. It has a worldwide, loyal network of advisers and experienced strategic partners. Merlin invests in companies that are bringing to market human medicines or medical devices with groundbreaking technology and great commercial potential. It has a reputation as an attractive partner for management teams who can create substantial value for investors.
A high resolution photograph is available via ISDN from Newscast and at http://www.newscast.co.uk (Tel: +44 (0)20 7608 1000)
510(k) Summary
McCue Energist ULTRATM Pulsed Light System
This 510(k) summary of safety and effectiveness for the McCue Energist ULTRA pulsed
light system by McCue PIc is submitted in accordance with the requirements of the Safe
Medical Device Act (SMDA) of 1990 and follows the Office of Device Evaluation (ODE)
guidance concerning the organisation and content of a 510(k) summary.
Aplicant: McCue PIc
Address: Unit 27 Solent Indust. Estate, Hedge End, S outhamS0p2to3n-2 FY. England
Contact Person: Steven Peach (General and Technical Manager)
Telephone: 44 1489 795668
Preparation Date: 19th February 2004
Device Trade McCue Energist ULTRATM
Name:
Common Name: Intense Pulsed Light System
Classification Laser surgical instrument for use in General and Plastic surgery and Dermatology
Name 21 CFR 878.4810
Product Code: GEX
Panel: 79
Legally-Marketed The McCue Energist ULTRATMis substantially equivalent to the following
Predicate currently marketed devices:
Devices: Lumenis, Inc. FPL Quantum, K020839
Radiancy, Inc. SpaTouch, K020856
Radiancy, Inc. Skin Station, K030897
Palomar, Inc. EsteLux, K020453, K020941
Alderm/MBC, Prolite/Plasmalite, K013365, K022568, K023081
System The McCue Energist ULTRA TM is a light-based medical device that delivers a
Description: beam of pulsed non-ionising radiation in the region of 530nm to 950nm. The
system has been designed to be compact and self-contained that includes:
- Control console unit
- Display panel
- Power supply
- Cooling system
- Removable handpiece with integrated switch, lamp, filter and glass
coupling block
intended Use: The McCue Energist ULTRA’ m VPL Intense Pulsed Light System is intended for
permanent hair reduction. It is also indicated for photocoagulation of
dermatological vascular lesions, photothermolysis of blood vessels and the
treatment of benign pigmented lesions.
Intense Pulsed light Energy / wavelengths (530 - 950nm)
The 530-950nm intense pulsed wavelengths are indicated for:
The treatment of benign pigmented epidermal and cutaneous lesions
including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine
stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea,
melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg
veins, facial veins and venous malformations.
1201
51 OK summary for ultra 7.doc 25/05/2004 issue 7 page I of 2 - Intense Pulsed light Energy / wavelengths (610 - 950nm)
The 610-950nm intense pulsed wavelengths are indicated for:
The removal of unwanted hair from all skin types, and to effect stable
long-term or permanent" hair reduction in skin types I -V through
selective targeting of melanin in hair follicles.
Permanent hair reduction is defined as a long-term stable reduction in the
number of hairs regrowing after a treatment regimen.
Performance The differences in specifications of the McCue Energist ULTRATM and the
Data: predicate devices do not result in different performance or raise new questions of
safety and efficacy.
Conclusion: Based on the foregoing, the McCue Energist ULTRATM system is substantially
equivalent to the legally-marketed predicate devices.
1202
510K summary for ultra 7.doc 25/05/2004 issue 7 page 2 of 2
DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850
JUN - 12004
McCue PLC
c/o Mr. John W. Howlett
British Standards Institution
Maylands Avenue
Hemel Hempstead
Herts HP2 4SQ
United Kingdom
Re: K040659
Trade/Device Name: McCue Energist ULTRATM VPL Intense Pulsed Light System
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser surgical instrument for use in general and
plastic surgery and in dermatology
Regulatory Class: IL
Product Code: GEX
Dated: May 12, 2004
Received: May 20, 2004
Dear Mr. Howlett:
We have reviewed your Section 510(k) premarket notification of intent to market the device
referenced above and have determined the device is substantially equivalent (for the indications
for use stated in the enclosure) to legally marketed predicate devices marketed in interstate
commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to
devices that have been reclassified in accordance with the provisions of the Federal Food, Drug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).
You may, therefore, market the device, subject to the general controls provisions of the Act. The
general controls provisions of the Act include requirements for annual registration, listing of
devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration.
If your device is classified (see above) into either class IX (Special Controls) or class III (PMA), it
may be subject to such additional controls. Existing major regulations affecting your device can
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may
publish further announcements concerning your device in the Federal Re ister.
Please be advised that FDA’s issuance of a substantial equivalence determination does not mean
that FDA has made a determination that your device complies with other requirements of the Act
or any Federal statutes and regulations administered by other Federal agencies. You must
comply with all the Act’s requirements, including, but not limited to: registration and listing (21
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Page 2 - Mr. John W. Howlett
This letter will allow you to begin marketing your device as described in your Section 510(k)
premarket notification. The FDA finding of substantial equivalence of your device to a legally
marketed predicate device results in a classification for your device and thus, permits your device
to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled,
“Misbranding by reference to premarket notification” (21CFR Part 807.97). You may obtain
other general information on your responsibilities under the Act from the Division of Small
Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or
(301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
V Celia M. Witten, Ph.D., M.D.
Director
Division of General, Restorative
and Neurological Devices
Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
Indications for Use
510(k) Number (if known): K040659
Device Name: McCue Enerpist ULTRAT VPL Intense Pulsed Light System
Indications for Use:
The McCue Energist ULTRATM VPL Intense Pulsed Light System is intended for permanent hair reduction. It is
also indicated for photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels and the
treatment of benign pigmented lesions. - Intense Pulsed light Energy / wavelengths (530 - 950nm)
The 530-950nm intense pulsed wavelengths are indicated for:
The treatment of benign pigmented epidermal and cutaneous lesions including warts, scars and striae.
The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal
and leg telangiectasias, rosacea, melasma, angiomas and spider angiormas, poikiloderma of Civatte, leg
veins, facial veins and venous malformations. - Intense Pulsed light Energy / wavelengths (610- 950nm)
The 610-950nm intense pulsed wavelengths are indicated for:
The removal of unwanted hair from all skin types, and to effect stable long-term or permanent hair
reduction in skin types I -V through selective targeting of melanin in hair follicles.
Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a
treatment regimen.
Prescription Use X Over-The-Counter Use
(Part 21 CFR 801 Subpart D) OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LFNE-CONT[NUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page I of I
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
D2
510(k) Number /L VO6S-?
Thanks for the reply.but has anyone tried it or even heard about this device?They say that it’s designed so that each shot of light comprises a sequence of rapid pulses that ensure more controlled absorption whilst minimising heating of the skin, so you can get output energy up to 51J
This device is cleared for lower wavelengths only, meaning that darker skin tones might not be ideal for this.
I had Palomar pulsed light treatment done on my underarms this morning. I have no experience with laser, although several years ago I had some electrolysis. (The professional electrolysis I had was unsuccessful in that there was no significant hair reduction: the few hairs I removed myself with a home machine have never grown back!)
Certainly it will be months before the pulsed light results are measurable, but I can describe the procedure now. It took perhaps 10 minutes or less. The technician put a salve of some kind on my underarms and then proceeded to put the ‘wand’ over the area. It emitted a blast of light onto the hair every few seconds. It felt like a quick burn, but was no more painful than my memory of electrolysis. There was a smell of burning, presumably the hair above the skin. When the area was completed, the technician put more salve (the same or different, I was too tense to retain the information) and an ice pack under my arms. I feel ever so slightly uncomfortable now, but I felt the same before the procedure as I had shaved my underarms closely and they felt raw. The sensation is identical, and the discomfort may be due to the shaving as much as the treatment.
The cost was $75 Canadian dollars. That was half price, as the technician is starting on her own after having worked in a doctor’s office. I was unable to have legs done as I am still tanned. I will be trying that next.
I would love a life free of excess hair and the inconvenience, expense and pain it causes. I have had no luck with other hair removal systems, but am hopeful for this. I’ll keep in touch.
Nearly two years ago, I had patch tests done with both IPL and a CoolGlide ND:Yag laser. I wasn’t impressed with the IPL at all.
However, now a lot of clinics seem to be getting VPL machines. Naturally, they all swear these are far superior than any other machine ever produced! I’m sceptical, to be honest… Does anyone know what the difference between IPL and VPL is?
Nearly two years ago, I had patch tests done with both IPL and a CoolGlide ND:Yag laser. I wasn’t impressed with the IPL at all.
However, now a lot of clinics seem to be getting VPL machines. Naturally, they all swear these are far superior than any other machine ever produced! I’m sceptical, to be honest… Does anyone know what the difference between IPL and VPL is?
I have noticed this too. My practitioner told me that plasctic surgeons and dermatologists now say that IPL is the way to go. I am skeptical of their claims, but I am open minde. I am going to try an IPL (or was it VPL?) machine this Tuesday on my upper legs. I think the one I am going to try is officially called an AFT (Advanced Fluorescence Technology). It may be the Harmony device. I will report back with my conclusions.
I may get to try a Cutera Prowave 770 IPL device (useable on dark skin) and hopefully a Coolglide CV Laser in November. I am most optimistic about the Coolglide CV. It has a large spot size and individual control over fluence and pulse width.
Now that my chest and armpits are virtually cleared, I’m going to concentrate on my arms and legs.
RJC2001