Manufacturer
Biolase, Inc.WATERLASE IPLUS S
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K141975
- Device name
- WATERLASE IPLUS S
- Company
- Biolase, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2014-07-21
- Decision date
- 2015-03-05
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
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 benign tumors, decubitus 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,
Intended 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.
Device Description
The Waterlase iPlus S system is an erbium, chromium, yttrium, scandium, gallium, garnet (ER,CR:YSGG) solid state laser that provides optical energy to the user-controlled distribution of atomized water droplets at 2.78 µm (2780 nm). The laser consists of a cabinet which houses the power supply, the cooling system, micro-controller, laser, foot switch, and fiber optic for delivery of laser energy with the fiber optic handpiece. Various handpiece and tip types are available depending upon the clinician's preference for the different applications. The Waterlase iPlus S system utilizes direct laser energy either with or without water for cooling and hydration to perform soft tissue incision, excision, resection, ablation, vaporization, coagulation and hemostasis.
Summary parsed at:2026-06-01 06:10:13 UTC
