# K032459: Profile 1320 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Mar 9, 2004 after 211 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: 4 generations back to K820106 (1982). 20 ancestors in all.
518 later devices descend from it; 3 cite it directly.
0 of 539 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022466: Profile 1320 Laser System, Sciton, Inc (2002) Summary page 1.
- K022381: Profile 1320 Laser System, Sciton, Inc (2002) Summary page 1.
- K031184: Cool Touch 3, New Star Lasers, Inc. (2003) Summary page 1.
- K030453: Cooltouch ND: Yag Laser System, New Star Lasers, Inc. (2003) Summary page 1.
- K022817: Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag Laser System, Model Cooltouch-II, Icn Pharmaceuticals, Inc. (2002) Summary page 1.
- K014035: Cooltouch and Cooltouch-II ND:Yag Laser Systems, Cooltouch Corp. (2002) Summary page 1.
- K012982: Cooltouch Varizoom, New Star Lasers, Inc. (2001) Summary page 1.
- K022884: Candela Smoothbeam Laser System, Candela Corp. (2003) Summary page 1.
- K014128: Candela Smoothbeam Laser System, Candela Corp. (2002) Summary page 1.
- K013825: Candela Smoothbeam Laser System, Candela Corp. (2002) Summary page 1.

## Most influential descendants
- 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
- K083899: Revlite Q-Switched ND:Yag Laser System (2009), 198 descendants of its own

## Indications for use
The Sciton, Inc. Profile 1320 Laser is intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue. It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.

Source page: https://510kreport.com/device/K032459
Methodology: https://510kreport.com/methodology