# K991285: Laser System Rubystar with Q-Switch and Normal Mode

- Pathway: 510(k) (Traditional)
- Applicant: Aesculap-Meditec North America
- Decided: Jul 12, 1999 after 88 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) MLT R694: named in the summary without a submission number
- (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
- (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) Sharplan EpiTouch: 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 laser system Ruby Star (operating in normal use) is intended to remove unwanted body hair. The laser system Ruby Star (operating in Q-Switch mode) is indicated for cutting, vaporization, or ablation of soft tissue. This includes tattoo removal and treatment of benign pigmented lesions. Some examples of pigment lesions are: Lentigines, Cafe-au-lait-blotches, Ephalides, Benign Naevi such as Nevus of Ota, Naevus of Ito, Epidermal naevi, Congenital naevi, Becker’s naevi, Blue naevus, Naevus spilus, and Mongolian spot. The laser system Ruby Star is restricted to sale or use by licensed professionals in the United States

Source page: https://510kreport.com/device/K991285
Methodology: https://510kreport.com/methodology