# K150027: CYMA

- Pathway: 510(k) (Traditional)
- Applicant: Whitecap Technologies, LLC
- Decided: Apr 3, 2015 after 86 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K910422 (1992). 157 ancestors in all.
No later device cites it as a predicate yet.
0 of 158 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123573: Youlaser CO2 Laser, Quanta System Spa (2013) Summary page 4.

## 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.

Source page: https://510kreport.com/device/K150027
Methodology: https://510kreport.com/methodology