# K970667: Nuvo-Lase 660 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: American Laser Medical
- Decided: May 13, 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.
94 later devices descend from it; 2 cite it directly.
0 of 95 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) Laserscope Aura: named in the summary without a submission number
- (no number) Lihtan 532: named in the summary without a submission number

## Most influential descendants
- K020071: Viridis Derma Laser (2002), 92 descendants of its own
- K091534: Lightlas Model 532 (2009), 72 descendants of its own
- K100558: Quanta Diode Laser System (2010), 68 descendants of its own
- K102755: Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/ 1470NM Fiber-Coupled Diode Laser (2010), 46 descendants of its own
- K110080: Radial-Emitting Shaped Fiber Optic Delivery System (2011), 26 descendants of its own

## Indications for use
The Nuvo-Lase 660 Laser is intended for use in the treatment of selected pigmented and vascularized lesions of the skin. Representative indications for use are: Nuvo-Lase Model 660 Laser System For vascular lesions: (Green - 532 nm) 1. Capillary Hemangioma (port wine hemangioma) 2. Strawberry hemangioma 3. Telangiectasia 4. Rosacea For pigmented lesions: (Green - 532 nm). 1. Freckles 2. Age Spots 3. cCafe-au-lait 4. Lentigo

Source page: https://510kreport.com/device/K970667
Methodology: https://510kreport.com/methodology