# K031680: Spectrapulse

- Pathway: 510(k) (Traditional)
- Applicant: Primary Technology, LLC
- Decided: Jun 24, 2003 after 25 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: 6 generations back to K910422 (1992). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller, Palomar Medical Technologies, Inc. (2002)
- K994014: Esc Intense Pulsed Light Systems: Epilight and Multilight, Esc Medical Systems, Ltd. (2000) Summary page 1.
- K991935: Epilight Hair Removal System, Photoderm HR System, Esc Medical Systems, Ltd. (2000) Summary page 1.
- K963249: Epilight Hair Removal System, Esc Medical Systems, Ltd. (1997) Summary page 1.

## Indications for use
The SpectrapulseB pulsed light system is intended for photothermolysis of blood vessels (facial and leg veins), photocoagulation of dermatological vascular lesions, and the treatment of benign pigmented lesions for skin types I - IV according to the Fitzpatrick scale. The Spectrapulse09 pulsed light system is intended for long term hair removal on skin types I-V according to the Fitzpatrick scale.

Source page: https://510kreport.com/device/K031680
Methodology: https://510kreport.com/methodology