# K982113: Umeco Optima 694 Ruby Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Umeco, Inc.
- Decided: Sep 30, 1998 after 106 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) Derma-Lase DLR-1: named in the summary without a submission number
- (no number) Spectrum RD 1200 Ruby laser system: named in the summary without a submission number

## Indications for use
The Umeco OPTIMA 694 system is intended for the use in the removal of blue/black tattoos and benign pigmented lesions in dermatology and plastic surgery.

Source page: https://510kreport.com/device/K982113
Methodology: https://510kreport.com/methodology