CYMA

Whitecap Technologies, LLC

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

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1

Cited as predicate

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Device details

FDA 510(k) registration fields

K number
K150027
Device name
CYMA
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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