# K022466: Profile 1320 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Dec 31, 2002 after 159 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 K820106 (1982). 8 ancestors in all.
520 later devices descend from it; 2 cite it directly.
0 of 529 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003715: Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model Cooltouch, Cooltouch II, Cooltouch Corp. (2001)
- K014035: Cooltouch and Cooltouch-II ND:Yag Laser Systems, Cooltouch Corp. (2002) 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 intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periorbital and perioral wrinkles.

Source page: https://510kreport.com/device/K022466
Methodology: https://510kreport.com/methodology
