# K040005: Profile 2000/3000 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Mar 29, 2004 after 87 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
No predicates in its family tree.
572 later devices descend from it; 6 cite it directly.
0 of 573 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Trimedyne Holmium Laser System: named in the summary without a submission number
- (no number) Surgical Laser Technologies LaserPro CTH Holmium Laser System: named in the summary without a submission number
- (no number) Lumenis VersaPulse Holmium and Dual Wavelength Surgical Lasers & Delivery Devices with Accessories: named in the summary without a submission number
- (no number) New Star Holmium Laser System: named in the summary without a submission number
- (no number) Erbium 2000 Laser Family: named in the summary without a submission number
- (no number) FutureLase 3000/3002 Erbium Laser System: named in the summary without a submission number
- (no number) Schwartz Electro-Optics CLR 2940 Erbium CrystaLase: named in the summary without a submission number
- (no number) Laserscope VELA Erbium:YAG Laser System and Accessories: named in the summary without a submission number

## 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 Profile 2000 Laser System, and Delivery Devices and Accessories, is 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: Dermatoloqv 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. Gastroenteooical/Graostrointestinal Surqer 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. Geeneral Surger General surgery of soft tissues, including; skin incision, tissue dissection, excision of external tumnors 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, parothyroidectomy, herniorrhaphy, tonsillectomy, lymphadenectomy, partial nephuectomy, pilonidal cystectomy, resection of lipoma, pelvc adhesiolysis, debridement of decubitus ulcer, hemorrhoids, pilonidal cyst removal and repair, debridement of statis ulcer, biopsy, appendectomy, pytorostenotomy, removal of polyps of the sigmoid colon, lysis of adhesions, cholecystectomy. Genitourinarv SurciervlUrology Genitourinary surgery of soft tissue, including: treatment of bladder, urethral and ureteral tumors: superficial urinary bladder tumors; invasive bladder carcinomas;, urethral and penile hemangiomna; urethral strictures; lesions of the extemnal genitalia; condylornas; bladder neck obstructions. Endoscopic transurethral incision of prostate, bladder neck incision of the prostate, laser ablation, enucleation and resection of prostate, hernostasis, vaporization and excision for treatment of benign prostatic hypertrophy. -PyncociaSuer Gynecological surgery Of Soft tissue, including condyloma acurninata. Lithotripsv and _PercutaneusUrnaryLLthotrinsy Lithotripsy and percutaneous urinary lithotripsy, including: fragmentation of uninary 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 woires cannot be passed. Lumbar DiscectpMy Lumbar discectomy in soft, cartilaginous and bony tissue, including: vaporization of the L.4-5 and L.6-SI lumbar discs of the vertebral spine; open, percutaneous and endos-copic spine procedures; foraminotomy. Ortho~eclJp Surgery Orthopedic surgery in soft and cartilaginous tissue in small and large joints (excluding the spine), including: knee Meniscectomy, knee synovectomy, chondrornalacia and tears, loose body debridement, lateral retinacular release, plica removal, ligament and tendon release, contouring and sculpting of articular surfaces, debridernent of inflamed synovial tissue, loose body debridemnent, capsulectomny in the knee, chondroplasty in the knee, chondromalacia ablation. Otorhinolarvriooial(NISurgM Otorbinolaryrigological (ENT) surgery in soft, mucosal, cartilaginous and bony tissue, including. endosinus surgery, functional endoscopic sinus surgery, turbinate procedures (e.g. turbinoplasty, turbinectomny), dacryocystorhinostomy (DCR), ethmoidectormy, polypectomy, maxillary antrotorny, frontal sinusotomy, sphenoidotomny, hereditary hemorrhagic telangectasia, septoplasty. Pulmonar- Su~rgery Open and endoscopic pulmonary surgery. The Profile 3000 Laser System, and Delivery Devices and Accessories, is indicated 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 meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs and glands. Aesthe~tic Surget Skin resurfacing and treatment of wrinkles. Deertooy&PatcSrg~y Indications include, epidermal nevi, telangietasia, spider veins, actinic cheilitis, keloids. verrucae. skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers. Gastroenterology. General Surgery The Erbium;YAG laser 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. GenjtpurinaryUmlog~y_ Gvnecolgy Indications include cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma. .phthalmolg. Indications include soft tissue surrounding the eye and orbit and anterior capsulotomy. Oral/Maxillofacial Otorhinolarriaog~oica4l (ENT) Sqrlery Podjqatr Indications include warts, plantar verruae, large mosaic verrucae and matrixectomy. Pulmonary Surciery Thoracic Suraery

Source page: https://510kreport.com/device/K040005
Methodology: https://510kreport.com/methodology