# K022381: Profile 1320 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Oct 18, 2002 after 88 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: 1 generation back to K002347 (2000). 1 ancestor in all.
519 later devices descend from it; 1 cites it directly.
0 of 521 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K002347: Cooltouch II, New Star Lasers, Inc. (2000) Summary page 1.

## Most influential descendants
- K032459: Profile 1320 Laser System (2004), 518 descendants of its own
- K042000: Modified MSQ Family of Lovely Light/Laser Systems (2004), 517 descendants of its own
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own

## Indications for use
The Profile 1320 Laser System is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue.

Source page: https://510kreport.com/device/K022381
Methodology: https://510kreport.com/methodology