# K991798: Acme Medical Aesthetic ND:Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Altus Medical
- Decided: Mar 6, 2000 after 285 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: 4 generations back to K963094 (1996). 10 ancestors in all.
745 later devices descend from it; 10 cite it directly.
0 of 756 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973324: Starlight Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1997) Summary page 1.
- K971737: Cynosure Photogenica Lpir Dermatological Laser, Cynosure, Inc. (1997) Summary page 1.
- K981351: Candela Gentlelase GL Dermatological Laser, Candela Corp. (1998) Summary page 1.

## Most influential descendants
- K014040: Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and Future Models (2002), 739 descendants of its own
- K022226: Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future Models (2002), 665 descendants of its own
- K022923: Candela Gentle Yag Laser System (2003), 656 descendants of its own
- K023193: Candela Gentle Yag Laser System (2002), 656 descendants of its own
- K033172: Candela Gentleyag Family of Laser Systems (2003), 654 descendants of its own

## Indications for use
The Altus Medical Aesthetic Nd:YAG Laser is intended for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialties of general and plastic surgery and dermatology for: the removal of unwanted hair in Fitzpatrick skin types I-V.

Source page: https://510kreport.com/device/K991798
Methodology: https://510kreport.com/methodology