# K963389: Flex-Lase 600 Series Ion Laser System

- Pathway: 510(k) (Traditional)
- Applicant: American Laser Medical
- Decided: Nov 26, 1996 after 90 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 K903883 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913569: Compac a, Elite a, Elite a Plus, Surgica a, Hgm Medical Laser Systems, Inc. (1991) Summary page 6.
- K903883: Vasculase (R) Copper Vapor Laser Syst, Pigment Les, Metatech Corp. (1990) Summary page 6.
- (no number) Coherent Artisan: named in the summary without a submission number

## Cited in the summary but kept off the family tree
- K913428: NGM Spectrum K1. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 6.

## Indications for use
The Flex-lase 600 Ion Laser is intended for use in the treatment of selected pigmented and vascularized lesions of the skin. Representative indications for use are: Flex-Lase Model 640 Laser System For vascular lesions: (Yellow - 568 nm) 1. Capillary Hemangioma (port wine hemangioma) 2. Strawberry hemangioma 3. Telangectasia 4. Rosacea For pigmented lesions: (Yellow/Green - 568 nm and 520-530 nm) Freckles Age Spots Cafe-au-lait Lentigo Flex-Lase Model 620 Laser System For Vascular lesions: (Blue/Green - 488 nm and 514.5 nm) 1. Capillary Hemangioma (port wine hemangioma) 2. Strawberry Hemangioma 3. Telangectasia 4. Rosacea For pigmented lesions: (Green - 514.5 nm) 1. Freckles 2. Age Spots 3. Cafe-au-lait 4. Lentigo

Source page: https://510kreport.com/device/K963389
Methodology: https://510kreport.com/methodology