# K983054: Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND: Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Continuum Biomedical, Inc.
- Decided: Feb 10, 1999 after 162 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: 2 generations back to K950019 (1995). 2 ancestors in all.
748 later devices descend from it; 5 cite it directly.
0 of 751 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973719: Medlite Q-Switched ND:Yag Laser, Medlite IV Q-Switched ND:Yag Laser, Continuum Biomedical, Inc. (1997) Summary page 1.
- K950019: Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100, Thermolase Corp. (1995) Summary page 1.

## Most influential descendants
- K022709: Medlite Q-Swithced Laser (2003), 742 descendants of its own
- K033946: Lovely System (2004), 737 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 the removal or lightening of unwanted hair in the 1064nm mode only without adjuvant preparation using one or two treatments.

Source page: https://510kreport.com/device/K983054
Methodology: https://510kreport.com/methodology