Millennium Dental Technologies, Inc.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
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. Oropharyngeal / 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 • Cholecystectomy • Debridement of decubitus ulcers • Hemorrhoidectomy • Hepatectomy • Herniorrhaphy • Lymphad
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.
The PerioLase Nd:YAG Pulsed Dental Laser System consists of a flashlamp-pulsed Nd:YAG rod in an optical resonant cavity. The energy and the width of each laser pulse are determined by the size and shape of the current pulse through the flashlamp. The current pulse is controlled by a solid-state switching circuit based on a microprocessor controller. The output energy of each laser pulse is measured by an internal energy monitor, and adjustments are made if necessary. The laser beam is coupled into a fiber-optic cable, and the system includes safety features such as a remote interlock connector and a laser stop button. The system operates at a wavelength of 1.064 microns (1064 nm) with a pulse energy range of 20 to 300 mJ, pulse width of 100 µsec to 650 µsec, and a repetition rate of 10 to 100 Hz. The average power is 6 Watts maximum, and it is classified as Class IV.
Summary parsed at:2026-06-01 05:54:46 UTC
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