# K980187: MLT R694 Ruby Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Laser Technologies, Ltd.
- Decided: Apr 3, 1998 after 73 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.
4 later devices descend from it; 1 cites 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)
- None. The FDA summary names its predicate without a number.
- (no number) EpiLaser: named in the summary without a submission number
- (no number) Chromos 694: named in the summary without a submission number
- (no number) EpiTouch: named in the summary without a submission number

## Most influential descendants
- K990902: Modification of MLT R694 Ruby Laser System (1999), 3 descendants of its own
- 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 is intended to remove unwanted body hair. Patient selection criteria include patients with skin types 1-4.

Source page: https://510kreport.com/device/K980187
Methodology: https://510kreport.com/methodology