# K011747: Palomar LC 100 Diode Laser

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Technologies, Inc.
- Decided: Aug 30, 2001 after 86 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: 4 generations back to K950019 (1995). 10 ancestors in all.
174 later devices descend from it; 3 cite it directly.
0 of 185 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K994225: Palomar SLP 2000, Palomar Medical Technologies, Inc. (2000) Summary page 1.
- K010580: Palomar SLP 1000, Palomar Medical Technologies, Inc. (2001) Summary page 1.
- K973324: Starlight Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1997) Summary page 1.
- K974346: Starlight Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1998) Summary page 1.
- K982940: Lightsheer Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1999) Summary page 1.
- K001746: Lightsheer Pulsed Diode Array Laser System (Family of Products), Coherent Star (2000) Summary page 1.
- K003614: Lightsheer Pulsed Diode Array Laser System, Coherent Star (2001) Summary page 1.

## Most influential descendants
- K032846: Spectra Pulsed Diode Laser, Model DR-1 (2003), 173 descendants of its own
- K052848: Spectra Hair Removal Laser (2005), 172 descendants of its own
- K060839: Abc Hair Removal System (2006), 171 descendants of its own
- K053527: Spectra Hair Removal Laser (2008), 169 descendants of its own
- K072906: SILK'N (2008), 169 descendants of its own

## Indications for use
The LC100 diode laser system is indicated for hair removal and permanent hair reduction. Permanent hair reduction is defined as a long-term, stable reduction in the number of re-growing hairs after a treatment regime. The LC100 is also indicated for photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, hemangioma, spider nevi, and other benign vascular lesions; photothermolysis of blood vessels (treatment of facial and leg veins); removal of benign pigmented lesions, including lentigines, nevi, chloasma, and café-au-lait; incision/excision, ablation and coagulation (homeostasis) of soft tissue. The LC100 is indicated for use in patients with skin types I-VI, including tanned patients.

Source page: https://510kreport.com/device/K011747
Methodology: https://510kreport.com/methodology