# K983034: Cynosure CO3 ER:Yag Laser

- Pathway: 510(k) (Special)
- Applicant: Cynosure, Inc.
- Decided: Sep 10, 1998 after 10 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.
54 later devices descend from it; 2 cite it directly.
0 of 55 devices 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) Cynosure PhotoGenica ER Laser: named in the summary without a submission number

## Most influential descendants
- K050317: Burane XL (2005), 53 descendants of its own
- K052806: Burane (2005), 52 descendants of its own
- K082947: Lensx 550 Laser System (2009), 51 descendants of its own
- K094052: Lensx 550 Laser System. Model 550 (2010), 47 descendants of its own
- K092647: Lensx 550 Laser System (2009), 31 descendants of its own

## Indications for use
The Cynosure CO3 Er:YAG Laser is used for skin resurfacing, and for the incision, excision, ablation or vaporization of soft bodily tissues. Typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology, arthroscopy, general surgery, ENT and opthalmology.

Source page: https://510kreport.com/device/K983034
Methodology: https://510kreport.com/methodology