# K961006: Medlite/755 Alexandrite Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Continuum Biomedical, Inc.
- Decided: Sep 11, 1996 after 183 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 K950684 (1995). 1 ancestor in all.
3 later devices descend from it; 2 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)
- K950684: Cynosure Photogenica T10 Tattoo Removal Laser, Cynosure, Inc. (1995) Summary page 1.

## Most influential descendants
- K982316: Laseaway Alexandrite Laser System (1998), 1 descendant of its own
- K990043: Smoothlase Alexandrite Laser System (1999), 0 descendants of its own
- K980131: Alex TA2 Eraser (1998), 0 descendants of its own

## Indications for use
Treatment of pigmented lesions.

Source page: https://510kreport.com/device/K961006
Methodology: https://510kreport.com/methodology