# K013028: Palomar SLP 1000

- Pathway: 510(k) (Traditional)
- Applicant: Palomar Medical Products, Inc.
- Decided: Dec 6, 2001 after 87 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.
906 later devices descend from it; 6 cite it directly.
0 of 907 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) LightSheer Diode Array Laser: named in the summary without a submission number
- (no number) Laserscope Lyra G Surgical Laser System: named in the summary without a submission number

## Most influential descendants
- K024064: Polaris DS (2003), 681 descendants of its own
- K030186: Polris LV (2003), 680 descendants of its own
- K031671: Polaris WR (2003), 678 descendants of its own
- K051214: Aluma Skin Renewal System (2005), 476 descendants of its own
- K052324: Polaris LV, Lva Applicator (2005), 456 descendants of its own

## Indications for use
The Palomar Super Long Pulse, SLP™ 1000, diode laser system is indicated for the treatment of pseudofolliculitis barbae in Skin Types I-VI.

Source page: https://510kreport.com/device/K013028
Methodology: https://510kreport.com/methodology