# K991234: The Acme Medical Aesthetic ND:Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Acme Medical, Inc.
- Decided: Jun 28, 1999 after 77 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 K980537 (1998). 2 ancestors in all.
755 later devices descend from it; 4 cite it directly.
0 of 758 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980537: ND: Yag Accessory for Photoderm System, Esc Medical Systems, Ltd. (1998) Summary page 1.
- K981952: Combination ND:Yag and Frequency Doubled Solid State Green Laser, Instruments For Medicine and Diagnostics (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
- K993671: Candela Sclero Long Pulse Dye Laser (2000), 700 descendants of its own
- K013748: Candela Sclero Long Pulse Laser (Aka Vbeam) (2002), 699 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

## Indications for use
For coagulation and hemostasis of vascular lesions.

Source page: https://510kreport.com/device/K991234
Methodology: https://510kreport.com/methodology