# K990902: Modification of MLT R694 Ruby Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Laser Technologies, Ltd.
- Decided: May 27, 1999 after 70 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: 1 generation back to K980187 (1998). 1 ancestor in all.
3 later devices descend from it; 3 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980187: MLT R694 Ruby Laser System, Medical Laser Technologies, Ltd. (1998) Summary page 1.
- (no number) LaseAway Long Pulse and Q-Switched Ruby Laser: named in the summary without a submission number
- (no number) MM-Ruby Laser: named in the summary without a submission number
- (no number) Spectrum RD 1200: named in the summary without a submission number
- (no number) Candela AlexLAZR: named in the summary without a submission number

## Most influential descendants
- K040433: SINON (2004), 1 descendant of its own
- K150997: Ruby Star (2015), 0 descendants of its own
- K050218: Wavelight Sinon (2005), 0 descendants of its own

## Indications for use
The MLT R694 Ruby Laser System (operating in the Q-Switched mode) is indicated for cutting, vaporization, or ablation of soft tissue. This includes tatoo removal and treatment of benign pigmented lesions. The MLT R694 Ruby Laser System is restricted to sale to or use by licensed professionals in the United States

Source page: https://510kreport.com/device/K990902
Methodology: https://510kreport.com/methodology