# K141975: Waterlase Iplus S - Pathway: 510(k) (Traditional) - Applicant: Biolase, Inc. - Decided: Mar 5, 2015 after 227 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: 10 generations back to K910422 (1992). 239 ancestors in all. No later device cites it as a predicate yet. 0 of 240 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K052354: Oculase MD, Biolase Technology, Inc. (2006) Summary page 5. - K071734: Waterlase MD Derm, Biolase Technology, Inc. (2008) Summary page 5. - K060033: Profile Multi-Platform System, Sciton, Inc (2006) Summary page 5. - K971843: Laserscope Vela Erbium:Yag Laser System and Accessories, Laserscope (1997) Summary page 5. - (no number) Waterlase iPlus: named in the summary without a submission number ## Indications for use The Waterlase iPlus S is intended for use as a laser surgical instrument in the following medical specialties requiring the incision, excision, vaporization, ablation and coagulation of soft tissue: Dermatology/Plastic Surgery, Ear, Nose and Throat (ENT), Gastroenterology, General Surgery, Genitourinary/Urology, Gynecology, Ophthalmology, Oral/Maxillofacial Surgery, Podiatry, Pulmonary Surgery and Thoracic Surgery. It is indicated for the following expanded Indications for Use: Dermatology/Plastic Surgery: The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, telangiectasia, spider veins, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking of begin tumors, decubitis ulcers, cysts, diagnostic biopsy and skin resurfacing and treatment of wrinkles. Ear, Nose and Throat (ENT): The following indications can be used with the Angled or Straight Handpieces: 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 telangiectasias, septoplasty, lesions, polyps, cysts, hyperkeratosis, excision of carcinogenic tissue, oral leukoplakia. Gastroenterology: The following indications can be used with the Angled or Straight Handpieces: 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 following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coagulation may be indicated. Genitourinary/Urology: The following indications are used with the Angled Handpieces: 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, urethra and anus, penis, scrotum, (includes condyloma acuminate, giant perineal condyloma and verrucous carcinoma), vulvar lesions, polyps and familial polyps of the colon, bladder neck obstructions. The following indications are used with the Straight Handpieces: 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: The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: Cervical intraepithelial neoplasia (CIN), herpes simplex, endometrial adhesions, cysts and condyloma. Ophthalmology: The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: General ophthalmic soft tissue surgical indications such as: Incision, excision, vaporization and coagulation of ocular tissue and tissue surrounding the eye and orbit. Oral/Maxillofacial Surgery: The following indications can be used with the Angled, Contra-Angled or Straight Handpieces: 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. Podiatry: The following indications can be used with the Angled or Contra-Angled Handpieces: Warts, plantar verrucae, large mosaic verrucae and matrixectomy. Pulmonary Surgery: The following indications can be used with the Angled or Straight Handpieces: Open and endoscopic pulmonary surgery. Thoracic Surgery: The following indications can be used with the Angled or Straight Handpieces: Surgical incision/excision, vaporization and coagulation of soft tissue during any thoracic surgery. Source page: https://510kreport.com/device/K141975 Methodology: https://510kreport.com/methodology