Manufacturer
Whitecap Technologies, LLCCYMA
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K150027
- Device name
- CYMA
- Company
- Whitecap Technologies, LLC
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-01-07
- Decision date
- 2015-04-03
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cuttingSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
CYMA Co2 laser systems when used in non fractional mode is intended use for Incision, Excision, Ablation, Vaporization and Coagulation of body soft tissues including intraoral tissues, in medical specialties including Dermatology and Plastic surgery, Otorhinolaryngology (ENT), Gynecology, Neurosurgery, Dental and Oral Surgery and Genitourinary Surgery. When used in Fractional mode intended use for Skin Resurfacing.
Intended Use
CYMA Co2 laser systems when used in non fractional mode is intended use for Incision, Excision, Ablation, Vaporization and Coagulation of body soft tissues including intraoral tissues, in medical specialties including Dermatology and Plastic surgery, Otorhinolaryngology(ENT), Gynecology, Neurosurgery, Dental and Oral Surgery and Genitourinary Surgery. When used in Fractional mode intended use for Skin Resurfacing.
Device Description
The CYMA Co2 laser System are emitting a invisible infrared laser with maximum power of 30 watt at 10.63 um and consist of Infrared light laser oscillation in tubes; Power supplies, with non contacted mode hand pieces, LCD touch screen display, on this panel also has key switch, emergency red button and the operation led are inserted and consists of main function, Optic main Bench assemble, Fiber optic Hand pieces, Co2 laser Scanner laser tube: placed in the mixed crystals of copper pipe to the heater and produces a laser beam, Resonator: amplifies the beam, Cooling system, LCD control Panel, Foot Pedal Switch. Microcontroller manages the voltage and the Co2 laser Source. This converted light energy creates the Co2 infrared laser and exhaust from the crystal is amplified into a specific wave length. Laser energy produced is delivered to the tissue by means of an articulated arm and a specially designed multi spot Hand Piece. The Physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam, and is able to activate laser emission using Foot Switch.
Summary parsed at:2026-06-01 06:10:47 UTC
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