# K070388: Profile Multi-Platform System - Pathway: 510(k) (Traditional) - Applicant: Sciton, Inc - Decided: May 2, 2007 after 82 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: 13 generations back to K943450 (1995). 333 ancestors in all. 129 later devices descend from it; 8 cite it directly. 0 of 463 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K060033: Profile Multi-Platform System, Sciton, Inc (2006) Summary page 1. - K062321: Smartlipo ND:Yag Laser, Cynosure, Inc. (2006) Summary page 1. - K062822: Vari-Lase Endovenous Laser Console, Model 7500, Vascular Solutions, Inc. (2006) Summary page 1. - K051287: Vari-Lase Endovenous Laser Procedure Kit, Vascular Solutions, Inc. (2005) Summary page 1. - K062210: Cool Touch, Models CT3S, Ctev, NS160, Ctev, LC160, New Star Lasers, Inc. (2006) Summary page 1. - K061618: Cooltouch, Model Ctev, New Star Lasers, Inc. (2006) Summary page 1. - K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 1. - K003715: Cooltouch ND:Yag Laser System, Cooltouch-II ND:Yag Laser System, Model Cooltouch, Cooltouch II, Cooltouch Corp. (2001) Summary page 1. - K050673: Candela Family of Pulse Dye Laser Systems, Candela Corp. (2005) Summary page 1. - K043251: Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B, Candela Corp. (2005) Summary page 1. - K033461: Candela Vbeam Pulse Dye Laser System, Candela Corp. (2004) Summary page 1. - K033331: Candela Cbeam Pulse Dye Laser System, Candela Corp. (2004) Summary page 1. - K053616: Polaris WR, ST Applicator, Syneron Medical, Ltd. (2006) Summary page 1. - K031671: Polaris WR, Syneron Medical, Ltd. (2003) Summary page 1. - K041242: Candela Smoothbeam Laser System, Candela Corp. (2004) Summary page 1. - K051255: Lumiphase-R, Opusmed, Inc. (2005) Summary page 1. - K031425: Gentlewaves Led Photomodulation Device, Light Bioscience, LLC (2004) Summary page 1. - K042165: Cutera Tabletop Aesthetic Product, Cutera, Inc. (2004) Summary page 1. - K042630: Revlight Skin Care System, Skincare Technology, Inc. (2005) Summary page 1. ## Most influential descendants - K081352: Profile Multi-Platform System (2008), 112 descendants of its own - 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 ## Indications for use 1064 nm Indications for Use: Coagulation and hemostasis of benign vascular lesions such as, but not limited to telangiectasia and rosacea. Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin. The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles. Incision/excision and cutting, vaporization, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. It is further indicated for laser assisted lipolysis. 1320 nm Indications for Use: It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne, atrophic acne scars and mild to moderate inflammatory acne vulgaris. Profile Multi-Platform System with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity. 2940 nm Indications for Use: Skin resurfacing and treatment of wrinkles. Pulsed Light (300-1400 nm) Indications for Use: The Profile Multi-Platform Systems and Accessories are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. It is intended for use for: • The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); (515nm LP filter, 560nm LP filter) • The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; (560nm LP filter, 590nm LP filter) • The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction; and (590nm LP filter, 640nm LP filter, 695nm LP filter) • Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800nm LP filter) Source page: https://510kreport.com/device/K070388 Methodology: https://510kreport.com/methodology