# K101916: Joule Multi-Platform System - Pathway: 510(k) (Traditional) - Applicant: Sciton, Inc - Decided: Mar 18, 2011 after 252 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: 18 generations back to K943450 (1995). 496 ancestors in all. 111 later devices descend from it; 6 cite it directly. 0 of 608 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K081352: Profile Multi-Platform System, Sciton, Inc (2008) Summary page 1. - K081324: Candela Family of Q-Switched Alexandrite Lasers, Candela Corp. (2008) Summary page 1. - K072868: Accolade II Laser, Cynosure, Inc. (2007) Summary page 1. - K070388: Profile Multi-Platform System, Sciton, Inc (2007) Summary page 1. - K060033: Profile Multi-Platform System, Sciton, Inc (2006) Summary page 1. - K023881: Profile 1064 Laser System, Sciton, Inc (2003) Summary page 1. - K083899: Revlite Q-Switched ND:Yag Laser System, Hoya Conbio, Inc. (2009) Summary page 1. - K072564: Alma Lasers Harmony XL Multi-Application Platform, Alma Lasers, Ltd. (2008) Summary page 1. - K050382: Affinity QS Q-Switched ND:Yag Laser System, Cynosure, Inc. (2005) Summary page 1. - K083613: Quanta System Polysurge Diode Laser Family, Quanta System Spa (2008) Summary page 1. - K082230: Vectra Plus Laser System and Accessories, Xintec Corporation (2010) Summary page 1. - K082225: 15W Ceralas D 1470NM Diode Laser, Model D1470, Biolitec, Inc. (2008) Summary page 1. - K101506: LUX1540, LUX1440 & LUX2940 Laser Handpieces, Palomar Medical Technologies, Inc. (2010). Cleared while this submission was under review Summary page 1. - K090195: Palomar LUX1540 Handpiece, Palomar Medical Technologies, Inc. (2009) Summary page 1. - K070284: Fralex SR 1500 Laser System (Fralex II SR Laser System), Reliant Technologies, Inc. (2007) Summary page 1. - K100270: Artisan Aesthetic System, Palomar Medical Technologies, Inc. (2010) 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 - 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 - K143519: The MeDioStar NeXT Family (2015), 32 descendants of its own ## Indications for use The 755 nm Alexandrite system is designed for use in: The ClearScan ALX 755nm Alexandrite laser 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. Q-Switched 755 nm Alexandrite Indications for Use: The JOULE Q-Switched 755 nm Alex Multi-Platform Systems with accessories are indicated for the following uses: Pigmented Lesions Tattoos The 1064 nm Nd:YAG Indications for Use: Coagulation and hemostasis of benign vascular lesions such as, but not limited to, telangiectasias and rosacea. Removal of unwanted hair (for stable, long term or permanent hair reduction) through selective targeting of melanin in hair follicles and for the treatment of Pseudofolliculitis Barbae (PFB). Treatment of facial wrinkles. The JOULE 1064 nm Nd:YAG with fiber delivery is indicated for laser assisted lipolysis. Q-Switched 1064/532 nm Nd:YAG Indications for Use: The JOULE Q-Switched 1064/532 nm Nd:YAG Multi-Platform Systems with accessories are indicated for the following uses: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis. Specific Indications: 1064 nm wavelength Tattoo Removal (dark ink: blue and black) Nevus of Ota Removal or lightening of hair with or without adjuvant preparation Skin Resurfacing for Acne Scars and Wrinkles Benign Cutaneous Lesions, such as, but not limited to: striae and scars Reduction of Red Pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. 532 nm wavelength Tattoo Removal (light ink: yellow, red, light blue, green) Vascular Lesions including but not limited to: port wine stains/birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi Epidermal Pigmented Lesions including but not limited to: Cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus Other Pigmented Cutaneous Lesions including verrucae, skin tags, keratoses and plaques Skin Resurfacing for Acne Scars and Wrinkles Benign Cutaneous Lesions, such as, but not limited to: striae and scars Reduction of Red Pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. The 1319 nm Nd:YAG Indications for Use: Treatment of fine lines and wrinkles. Treatment of atrophic acne scars. Treatment of mild to moderate inflammatory acne vulgaris. The JOULE 1319 nm Nd:YAG with fiber delivery is indicated for laser assisted lipolysis. The JOULE 1319 nm Nd:YAG 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. 1470 nm Indications for Use: The JOULE 1470 nm Multi-Platform Systems and delivery accessories are intended for delivery of laser light to soft tissue for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The JOULE 1470 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue. 1550 nm Indications for Use: The JOULE 1550 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue. 2940 nm Indications for Use: The JOULE 2940 nm Multi-Platform Systems with delivery accessories are designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Aesthetic Surgery: Skin resurfacing and treatment of wrinkles. Dermatology & Plastic Surgery: Indications include epidermal nevi, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, and decubitis ulcers. It is also used for laser assisted site preparation for hair transplantation. The JOULE 2940 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing, and ablation and coagulation of soft tissue. BBL (300-1400nm) Indications for Use: The JOULE 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: Mild to moderate inflammatory and pustular inflammatory acne vulgaris. (420nm BP filter, 515nm LP filter, 560 LP filter) The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) (515nm LP filter, 560nm LP filter) The treatment of cutaneous lesions including warts, scars and striae; (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 (590nm LP filter, 640nm LP filter, 695 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. (800 nm LP Filter) The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to: Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling); Reduce discomfort during and/or associated with light or laser treatment; Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation; Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions). Source page: https://510kreport.com/device/K101916 Methodology: https://510kreport.com/methodology