# K971814: Improvements to the Mehl Ruby Laser

- Pathway: 510(k) (Traditional)
- Applicant: Mehl/Biophile Intl., Inc.
- Decided: Aug 1, 1997 after 78 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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) MEHL Ruby Laser for Hair Removal: named in the summary without a submission number

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

## Indications for use
The Chromos 694 (MEHL) Ruby Laser, Mark I, is indicated for the removal of unwanted body and facial hair.

Source page: https://510kreport.com/device/K971814
Methodology: https://510kreport.com/methodology