# K994225: Palomar SLP 2000

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Technologies, Inc.
- Decided: May 18, 2000 after 155 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: 3 generations back to K950019 (1995). 4 ancestors in all.
175 later devices descend from it; 1 cites it directly.
0 of 180 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973324: Starlight Pulsed Diode Array Laser System, Star Medical Technologies, Inc. (1997) Summary page 1.

## Most influential descendants
- K011747: Palomar LC 100 Diode Laser (2001), 174 descendants of its own
- 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

## Indications for use
The Palomar Super Long Pulse, SLP™ 1000, diode laser system is indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands, and specifically for the following indications. Dermatology and Plastic Surgery for: Hair Removal in Skin Types I-VI Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions. Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions Photothermolysis

Source page: https://510kreport.com/device/K994225
Methodology: https://510kreport.com/methodology