# K990452: Orlight 2000 Surgical Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Ybeam Technologies, Inc.
- Decided: Apr 29, 1999 after 76 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Coherent Ultrapulse Carbon Dioxide Lasers: named in the summary without a submission number
- (no number) Sharplan Carbon Dioxide SilkLaser: named in the summary without a submission number

## Indications for use
The OrLight 2000 CO, Surgical Laser System is intended for use in the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, including aesthetic surgery and resurfacing. The specific indications are as follows: Ablation, vaporization, excision, incision, and coagulation of sofl tissue in laser skin resurfacing, Jaser derm-abrasion, and laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for the treatment of wrinkles, rhytids, and furrows. Laser skin resurfacing (ablation, vaporization, excision, incision, and coagulation) for the reduction, removal and/or treatment of actinic keratosis, solar/actinic elastosis, actinic cheilitis, lentinges, uneven pigmentation/dyschromia, acne scars, surgical scars, keloids, hemangiomas, tattoos, telangiectasia, squamous cell carcinoma, epidermal nevi, xanthelasma palpebrarum, syringoma, and verrucae vulgares (warts). Laser incision and/or excision of soft tissue for the performance of laser blepharoplasty.

Source page: https://510kreport.com/device/K990452
Methodology: https://510kreport.com/methodology