# K060033: Profile Multi-Platform System

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Feb 28, 2006 after 54 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: 9 generations back to K910422 (1992). 228 ancestors in all.
221 later devices descend from it; 9 cite it directly.
0 of 450 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K023881: Profile 1064 Laser System, Sciton, Inc (2003) Summary page 1.
- K041879: Palomar LUX1064 Handpiece, Palomar Medical Technologies, Inc. (2005) Summary page 1.
- K032459: Profile 1320 Laser System, Sciton, Inc (2004) Summary page 1.
- K051434: Cooltouch ND:Yag Laser Systems, Models CT3S and Ctev, New Star Lasers, Inc. (2005) Summary page 1.
- K043046: Cooltouch, Model CT3S, New Star Lasers, Inc. (2005) Summary page 1.
- K042000: Modified MSQ Family of Lovely Light/Laser Systems, Msq (M2), Ltd. (2004) Summary page 1.
- K050738: FT Fiber Optic Delivery Systems, Fibertech GmbH (2005) Summary page 1.
- K040005: Profile 2000/3000 Laser System, Sciton, Inc (2004) Summary page 1.
- K051167: Revolix and Revolix JR, Allmed Systems, Inc. (2005) Summary page 1.
- K040270: Opusduo; Opusduo E; Opusduo EC; Opus 20; Opus Spectrum, Lumenis, Ltd. (2004) Summary page 1.
- K032460: Profile BBL System, Sciton, Inc (2003) Summary page 1.
- K051268: Radiance Acne System with Cleartouch Light Unit, Radiancy, Ltd. (2005)

## Most influential descendants
- K073063: 15W Ceralas D 1470NM Diode Laser (2008), 202 descendants of its own
- K083613: Quanta System Polysurge Diode Laser Family (2008), 192 descendants of its own
- K090164: Ceralas Multiwavelength 980/1470NM Diode Laser (2009), 177 descendants of its own
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own
- K082230: Vectra Plus Laser System and Accessories (2010), 112 descendants of its own

## Indications for use
The Profile Multi-Platform Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laparoscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. Dermatology: Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. 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. The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments. Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology. 1320 nm Indications for Use: The Profile Multi-Platform Systems and Accessories are intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and 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, 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 saphenous veins associated with varicose veins and varicosities. Profile 2000 nm Indications for Use: The Profile Multi-Platform Systems and Accessories are indicated for incision, excision, resection, ablation, vaporization, coagulation and hemostasis, with or without an endoscope, in contact and non-contact with tissue, with or without a hand piece, in the following indications: Dermatology and Plastic Surgery Dermatologic and Plastic Surgery of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, therapeutic dermatological and aesthetic surgical procedures, including: scars, tattoo removal, vascular lesions (including port wine stains, hemangioma, telangiectasias [facial, leg] and rosacea), corns, papillomas, basal cell carcinomas, lesions of skin and subcutaneous tissue, plantar warts, periungual and subungual warts, debridement of decubitus ulcer, skin tag vaporization. Gastroenterological/Gastrointestinal Surgery Open and endoscopic gastroenterologic surgery of soft tissue (for incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease. General Surgery General surgery of soft tissues, including: skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, and tissue ablations; removal of benign and malignant lesions: mastectomy, hepatectomy, pancreatectomy, splenectomy, thyroidectomy, parathyroidectomy, herniorrhaphy, tonsillectomy, lymphadenectomy, partial nephrectomy, pilonidal cystectomy, resection of lipoma, pelvic adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilonidal cyst removal and repair, debridement of statis ulcer, biopsy, appendectomy, pylorostenotomy, removal of polyps of the sigmoid colon, lysis of adhesions, cholecystectomy. Genitourinary Surgery/Urology Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors; superficial urinary bladder tumors; invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions. Endoscopic transurethral incision of prostate, ablation of benign prostatic hypertrophy, transurethral incision of prostate, laser resection of the prostate, laser enucleation of the prostate, laser ablation of the prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy. Gynecological Surgery Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, including condyloma acuminata, intra-uterine treatment of submucous fibroids, benign endometrial polyps and uterine septum by incision, excision, ablation and or vessel coagulation, soft tissue excision procedures such as excisional conization of the cervix. Lithotripsy and Percutaneous Urinary Lithotripsy Lithotripsy and percutaneous urinary lithotripsy, including: fragmentation of urinary calculi, fragmentation of calculi in the ureter and ureteropelvic junction, fragmentation of kidney calculi, fragmentation of urethral calculi and treatment of distal impacted fragments of steinstrasse when guide wires cannot be passed. Lumbar Discectomy Lumbar discectomy in soft, cartilaginous and bony tissue, including: vaporization of the L4-5 and L5-S1 lumbar discs of the vertebral spine; open, percutaneous and endoscopic spine procedures; foraminotomy. Orthopedic Surgery and Arthroscopy Orthopedic surgery in soft and cartilaginous tissue in small and large joints, including knee meniscectomy, knee synovectomy, chondromalacia and tears, loose body debridement, lateral retinacular release, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridement of inflamed synovial tissue, loose body debridement, capsulectomy in the knee, chondroplasty in the knee, chondromalacia ablation, ablation of soft and cartilaginous tissue in minimally invasive spinal surgery including percutaneous laser disc decompression/discectomy, foraminoplasty, ablation and coagulation of soft vascular and non-vascular tissue in minimally invasive spinal surgery. Otorhinolaryngological (ENT) Surgery Otorhinolaryngological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectomy), dacryocystorhinostomy (DCR), ethmoidectomy, polypectomy, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty, lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal, tonsillectomy, adenoidectomy. Thoracic and Pulmonary Surgery Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue, including laryngeal lesions, airway obstructions including carcinoma, polyps and granulomas, palliation of obstructing carcinomas of the tracheobronchial tree. 2940 nm Indications for Use: The Profile Multi-Platform Systems and Accessories are designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Soft tissue includes skin, subcutaneous tissue, striated and smooth tissue, muscle, cartilage, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Surgical specialties and applications include general surgery, plastic surgery, aesthetic surgery, dermatology, urology, gynecology, genitourinary, ENT, pulmonary surgery, thoracic surgery, podiatry, oral & maxillofacial surgery, ophthalmology (including oculoplasty), small and large joint arthroscopy, microdiscectomies, and endoscopic procedures. Aesthetic Surgery Skin resurfacing and treatment of wrinkles. Dental Application of Er:YAG It is indicated for a variety of hard tissue (tooth and bone) applications, and for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry. Hard Tissue Indications of Er:YAG Laser Energy: Caries removal, cavity preparation, enamel etching, enameloplasty, excavation of pits and fissures for placement of sealant. Bone Indications of Er:YAG Laser Energy: Contact and non-contact cutting, shaving, contouring, and resection of oral osseous tissue, apicoectomy, osseous crown lengthening, cutting bone to prepare a window access to the apex of the root, osseoplasty, osteotomy. Soft Tissue and Periodontal Indications of Er:YAG Laser Energy: Excisional and incisional biopsies, exposure of unerupted teeth, incision and drainage of abscesses, gingival incision and excision, gingivoplasties, gingivectomies, gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias, gingival troughing for crown impressions, hemostasis, implant recovery, frenectomies and frenotomies, fibromatosis, benign and malignant lesion removal, operculectomy, oral papillectomies, reduction of gingival hypertrophy, soft tissue crown lengthening, preprosthetic surgery (flabby alveolar ridge, vestibuloplasty, exposure of implants, hyperplasia, epulides, papillomas, fibromatoses, benign growths), vestibuloplasty, sulcular debridement. Endodontal Applications of Er:YAG Laser Energy: Tooth preparation to obtain access to root canal, pulpotomy, pulpotomy as an adjunct to root canal therapy, pulp extirpation, root canal debridement and cleaning, root canal preparation including enlargement. Dermatology & Plastic Surgery Indications include epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitus ulcers. It is also used for laser assisted site preparation for hair transplantation. Gastroenterology Gastroenterologic surgery of soft tissue, including: cholecystectomy, lysis of adhesions, appendectomy, biopsy, pylorostenotomy, benign and malignant lesions, rectal polyps of sigmoid colon, gall bladder calculi, biliary/bile duct calculi, benign and malignant neoplasm, polyps, colitis, ulcers, angiodysplasia, hemorrhoids, varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions, colorectal cancer, gastritis, bleeding tumors, pancreatitis, vascular malformations, telangiectasias, and telangiectasias of the Osler-Weber-Rendu disease. General Surgery The Er:YAG is intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any general surgery application where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, tissue ablation and/or vessel coagulation. Genitourinary/Urology Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors; superficial urinary bladder tumors; invasive bladder carcinomas; urethral and penile hemangioma; urethral strictures; lesions of the external genitalia; condylomas; bladder neck obstructions. Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hemostasis, vaporization and excision for treatment of benign prostatic hypertrophy. Gynecology Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma. Ophthalmology Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy. Oral/Maxillofacial Indications include oral/dental procedures for incision, excision, ablation, vaporization and hemostasis of soft tissue during gingivoplasties, gingivectomies, frenectomies, benign and malignant lesion removal, biopsies, leukoplakia and fibrotomy. Otorhinolaryngological (ENT) Surgery Otorhinolaryngological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue, including: endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectomy), dacryocystorhinostomy (DCR), ethmoidectomy, polypectomy, maxillary antrotomy, frontal sinusotomy, sphenoidotomy, hereditary hemorrhagic telangectasia, septoplasty. Podiatry Indications include warts, plantar verrucae, large mosaic verrucae and matrixectomy. Pulmonary Surgery Open and endoscopic pulmonary surgery. Thoracic Surgery Intended for the surgical incision/excision, vaporization and coagulation of soft tissue during any thoracic surgery. 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 tattoos (560nm LP filter, 590nm 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) * Treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis (350nm SP 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, 695 LP filter) * Mild to moderate inflammatory and pustular inflammatory acne vulgaris (420nm BP filter, 515nm LP filter, 560 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/K060033
Methodology: https://510kreport.com/methodology