# K081352: Profile Multi-Platform System

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Oct 23, 2008 after 162 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: 14 generations back to K943450 (1995). 352 ancestors in all.
112 later devices descend from it; 2 cite it directly.
0 of 465 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070388: Profile Multi-Platform System, Sciton, Inc (2007) Summary page 1.
- K070805: Ultrawave II EX 1320, Quanta System Spa (2007) Summary page 1.
- K042474: ARION, Wavelight Laser Technologie AG (2004) Summary page 1.
- K034030: Apogee Elite, Cynosure, Inc. (2004) Summary page 1.
- K024371: Candela Gentle Lase Family of Laser System, Candela Corp. (2003) Summary page 1.
- K024260: Candela Gentlelase Family of Laser Systems, Candela Corp. (2003) Summary page 1.
- K080121: Cynosure Smartlipo Multiwavlength Laser, Cynosure, Inc. (2008) Summary page 1.
- K072751: Cooltouch Models NS 160 and LC215 Coolipo, New Star Lasers, Inc. (2008) Summary page 1.
- K072779: Ceralas D 980NM Diode Laser, Models D15 and D25, Biolitec, Inc. (2008) Summary page 1.

## Most influential descendants
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own
- K132806: Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece (2014), 70 descendants of its own
- K143723: SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro (2015), 62 descendants of its own
- K140009: Soprano Ice Multi-Application & Multi-Technology Platform (2014), 57 descendants of its own
- K153671: Family of CoolGlide Aesthetic Lasers (2016), 32 descendants of its own

## Indications for use
755 nm Indications for Use: The 755 nm Profile Multi-Platform System with its accessories is indicated for stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I - VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions and wrinkles. 1320 nm Indications for Use: The 1320nm Profile Multi-Platform System with its accessories is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The Profile 1320nm laser is further indicated for laser assisted lipolysis. 2940 nm Indications for Use: The 2940 nm Profile Multi-Platform System with Profractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

Source page: https://510kreport.com/device/K081352
Methodology: https://510kreport.com/methodology