# K992597: Lorad LT-100 Laser Treatment System

- Pathway: 510(k) (Traditional)
- Applicant: Focus Medical, LLC
- Decided: Apr 24, 2000 after 265 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) ThermoLase SoftLight: named in the summary without a submission number
- (no number) Continuum Biomedical, Inc., Medlite: named in the summary without a submission number
- (no number) Continuum Biomedical, Inc., Medlite IV Q-Switched Nd:YAG Laser: named in the summary without a submission number

## Most influential descendants
- K170850: Alma Q (2017), 2 descendants of its own
- K233024: Alma Harmony (2024), 1 descendant of its own
- K252561: BTL-754FF (2026), 0 descendants of its own

## Indications for use
The Lorad LT-100 Laser Treatment System is intended for use: alone or in combination with an adjuvant lotion for the removal or lightening of upwanted facial or body hair. One or two treatments may be required for lightening or removing unwanted hair without the adjuvant lotion; in combination with the adjuvant lotion for skin resurfacing (ablation of epidermal skin layers) in dermatology and aesthetic surgery; dermal pigmented lesions (dermal melanocytosis); and for tattoo removal (dark and blue inks). The adjuvant lotion is a suspension of carbon powder in a base of Light Mineral Oil, NF. The Lorad LT-100 Laser Treatment System will be limited to use by licensed professionals (as provided in 21 CFR 801.109).

Source page: https://510kreport.com/device/K992597
Methodology: https://510kreport.com/methodology