# K970808: Medlite IV Q-Switched, Frequency Doubled, ND:Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Continuum Biomedical, Inc.
- Decided: Sep 5, 1997 after 184 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 K942622 (1995). 1 ancestor in all.
745 later devices descend from it; 3 cite it directly.
0 of 747 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K942622: Laseaway Q-Switched ND:Yag Laser System, Mdi, Inc. (1995) Summary page 1.

## Most influential descendants
- K033946: Lovely System (2004), 737 descendants of its own
- K033251: The Friendlylight ND: Yag Lasers (2004), 519 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K042630: Revlight Skin Care System (2005), 402 descendants of its own
- K041969: Aurora DS (2004), 302 descendants of its own

## Indications for use
For incision, exgision, ablation, vaporization in soft tissue for general dermatelogy - - - 1064nm wavelength: Dark ink (blue, black) tattoo removal Nevus of Ota 532nm wavelength: Light ink (red) tattoo removal Vascular lesions Epidermal pigmented lesions

Source page: https://510kreport.com/device/K970808
Methodology: https://510kreport.com/methodology