From a correspondent:
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I received my Cosmetic Surgery Times and there’s a large ad for the above system by Symedex. I checked the FDA 510(k) Releasable site and couldn’t find the system. Received the following: No records were found with ProductCode: GEX DeviceName: SpectraClear. Checked it out every which way, including perusing the whole FDA site.
Then I went to their website: http://www.symedex.com/index.html and couldn’t find anything about hair removal. Strange! The ad says: “In a flash…remove hair forever!” Claims SpectraClear “uses the perfect combination of Light and Heat Energy to provide dramatic and permanent hair reduction. Largest spot size, Affordable, safe and reliable.” Also … “it treats all hair colors and no messy gels or expensive cooling”
Have you heard of this device? I know the docs are not restricted and can use uncleared devices but am curious.
</font><hr /></blockquote><font size=“2” face=“Verdana, Helvetica, sans-serif”>I see no FDA information, but found an old name they did business under. They do have clearance by FDA for cellulite reduction. Nothing for SpectraClear™ Pulsed Light System (hair removal)
They do the spa, tanning salon and chiropractor circuit.
http://www.sybaritic.com/prodspec/prodspec.htm
Sybaritic, 800/445-8418
Customized Smart Spa Solutions training programs, includes training for treatments such as facials, massage, cellulite reduction, slimming, exfoliation, body wraps and masques.
Sybaritic, Inc. “See Calendar of Events., Training Seminars
Cellulite Reduction, Body Wraps & masks, Slimming & Contouring, etc.” Minneapolis MN 800-445-8418/612-888-8282
DEVICE: DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM
SCANDIA MANUFACTURING LTD. 510(k) NO: K003916(TRADITIONAL)
ATTN: RONALD E BERGLUND PHONE NO : 612-888-8282
9220 JAMES AVENUE SOUTH SE DECISION MADE: 15-APR-02
BLOOMINGTON, MN 55431 510(k) STATEMENT
®1999 Symedex LLC • 9220 James Avenue South • Minneapolis, MN 55431, USA • (800) 445.8418 • (612) 888-8282 • fax (612) 888-8887
Address:
9220 James Ave. South
Bloomington, MN 55431
UNITED STATES Phone: 1800 445 8418
Phone #2: 1 952 888 8282
Fax: 1 952 888 8887
Email: alpha33@sybaritic.com