# K182930: PerioLase Nd:YAG Pulsed Dental Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Millennium Dental Technologies, Inc.
- Decided: Jul 12, 2019 after 263 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: 13 generations back to K943450 (1995). 189 ancestors in all.
No later device cites it as a predicate yet.
0 of 190 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151763: PerioLase Nd:YAG Pulsed Dental Laser System, Millennium Dental Technologies, Inc. (2016) Summary page 6.
- K093547: Pinpointe Footlaser, Pinpointe USA, Inc. (2010) Summary page 6.
- K121508: Lightwalker at Lightwalker DT Lightwalker ST-E Lightwalker ST-N, Fotona D.D. (2012) Summary page 6.
- K011960: Lares Research Sunlase 800P Laser System (to BE Sold as Pocketpro or Pocketpro S4), Lares Research, Inc. (2001) Summary page 6.
- K971065: Dentica Pulsed ND: Yag Laser Systems and Accessories, Xintec Corporation (1997) Summary page 6.

## Indications for use
The PerioLase Nd:YAG Pulsed Dental Laser System is intended for use in laser surgery procedures for ablation, incision, excision, vaporization, and coagulation of soft tissues in specialties such as general and cosmetic dentistry, oral, maxillofacial, and cosmetic surgery, otolaryngology / ENT surgery, arthroscopy, dermatology and plastic surgery, gastroenterology, general surgery, gynecology, neurosurgery, ophthalmology, podiatry, pulmonary surgery, and urology. Orophayrngeal / Dental Surgery • Abscess incision and drainage • Aphthous ulcers treatment • Biopsies, incisional and excisional • Excision and ablation of benign lesions and conditions • Excision and vaporization of herpes simplex I and II • Exposure of unerupted / partially erupted teeth • Facilitation of subgingival calculus removal • Fibroma removal • Frenectomy • Frenotomy • Gingival incision and excision • Gingival troughing for crown impressions • Gingivectomy • Gingivoplasty • Hemostasis • Hemostatic assistance • Implant recovery • Incision of infection when used with antibiotic therapy • Laser-assisted new attachment procedure (cementum-mediated periodontal ligament new-attachment to the root surface in the absence of long junctional epithelium) • Laser-assisted uvulopalatoplasty (LAUP) • Lesion (tumor) removal • Leukoplakia • Modification of the dentin surface, including increasing the mineral and decreasing the organic composition of the dentin surface, reducing bacteria on the dentin surface, improving the shear bond strength of composite resin, reducing the adhesive failure of composite resin, and removing demineralized dentin surfaces • Operculectomy • Oral papillectomy • Periodontal regeneration – true regeneration of the attachment apparatus (new cementum, new periodontal ligament, and new alveolar bone) on a previously diseased root surface when used specifically in the LANAP® Protocol • Pulpotomy • Pulpotomy as an adjunct to root canal therapy • Reduction of denture hyperplasia • Reduction of gingival hypertrophy • Removal of filling material such as gutta percha or resin as an adjunct treatment during root canal retreatment • Removal of post-surgical granulations • Selective ablation of enamel (first degree) caries removal • Soft tissue crown lengthening • Sulcular debridement or soft tissue curettage (removal of diseased or inflamed soft tissue in the periodontal pocket) to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment level or loss, and tooth mobility • Tissue retraction for impression • Vestibuloplasty General Surgery Open, laparoscopic, and endoscopic general surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue). All soft tissue is included, striated and smooth tissue, muscle, cartilage, meniscus, mucous membrane, lymph vessels and nodes, organs and glands • Appendectomy • Cholecystecomy • Debridement of decubitus ulcers • Hemorrhoidectomy • Hepatectomy • Herniorrhaphy • Lymphadenectomy • Mastectomy • Pancreatectomy • Parathyroidectomy • Partial nephrectomy • Pelvic adhesiolysis • Pilonidal cystectomy • Removal of fibromas • Removal of lesions • Removal of polyps • Removal of tumors • Resection of lipoma • Splenectomy • Thyroidectomy • Tonsillectomy • Tumor biopsy Endonasal Surgery Endonasal surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: • Adenoidectomy • Lesions or tumors of the oral, nasal, glossal, pharyngeal and laryngeal tissues • Tonsillectomy Dermatology and Plastic Surgery Dematology and plastic surgery (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: • Debridement of decubitus ulcer • Hemangiomas • Lesions of skin and subcutaneous tissue • Periungual and subungual warts • Photocoagulation and hemostasis of pigmented and vascular lesions, such as, but not limited to, port wine stains, hemangiomae, warts, telangiectasiae, rosacea, venous lake, leg veins, and spider veins • Plantar warts • Port wine lesions • Removal of tattoos • Spider veins • Telangiectasia • Treatment of keloids • Treatment of mild to moderate inflammatory acne vulgaris • Treatment of wrinkles • Venous lakes Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: • Matrixectomy • Periungual and subungual warts • Plantar warts • Radical nail excision • Neuromas The PerioLase® MVP-7™ is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).

Source page: https://510kreport.com/device/K182930
Methodology: https://510kreport.com/methodology