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K Number
K170073
Device Name
LightMed Dental Laser System
Manufacturer
LIGHTMED DENTALTECHNOLOGY CORP.
Date Cleared
2017-07-25

(197 days)

Product Code
GEX
Regulation Number
878.4810
Type
Traditional
Panel
SU
Reference & Predicate Devices
K061966
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The LightMed Dental Laser System is intended for use in intraoral general dental surgery procedures, and in max!Ilofacial and cosmetic dentistry. It is intended for the incision, excision, vaporization, and coagulation of soft tissue and a variety of hard tissues (tooth and bone).

The LightMed Dental Laser System is indicated for the following oral and maxillofacial surgery and dentistry:

  • · Hard Tissue Indications of Erbium Laser Energy:
    • Caries removal
    • Cavity preparation
    • Enamel etching
    • Excavation of pits and fissures for placement of sealant
  • · Bone Indications of Erbium Laser Energy:
    • Shaving, contouring, and resection of oral osseous tissue (bone)
    • Apicoectomy amputation of the root end
    • Cutting bone to prepare a window access to the apex (apices) of the root(s)
    • Osteotomy
    • Osseous crown lengthening
  • · Soft Tissue and Periodontal Indications of Erbium Laser Energy:
    • Excisional and incisional biopsies
    • Exposure of unerupted teeth
    • Incision and drainage of abscesses
    • Gingival incision and excision
    • Gingivonlasties
    • Gingivectomies
    • Gingivectomy in case of hyperplasias of the gingival or excision of hyperplasias
    • Implant recovery
    • Frenectomies and frenotomies
    • Fibromatosis (fibroma removal)
    • Benign and malignant lesion removal
    • Operculectomy
    • Oral papillectomies
    • Reduction of gingival hypertrophy
    • Soft tissue crown lengthening
  • Preprosthetic surgery: flabby alveolar ridge, vestibuloplasty, exposure of implants, papillomas, fibromatoses benign growths, vestibuloplasty
  • Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility)
  • · Endodontal Indications of Erbium Laser Energy:
    • Tooth preparation to obtain access to root canal
    • Pulpotomy
    • Pulpotomy as an adjunct to root canal therapy
    • Pulp extirpation
    • Root canal debridement and cleaning
  • Root canal preparation including enlargement
Device Description

LightMed Dental Laser System is an erbium: yttrium aluminium garnet (Er: YAG) solid-state laser that provides optical energy at 2940 nm. LightMed Dental Laser System is a delicate integrate device of optical, mechanic, electronic, water and gas, which is consists of a control panel, system controller, laser applicator, power supplies and discharger, laser cooling module, spray water module, footswitch and external remote interlock connector. The laser console is embedded in the laser handpiece, delivers laser energy to the treatment site through a laser tip attached to a handpiece. The laser is activated by means of a footswitch. Various laser tips are available for different clinical applications. The LightMed Dental Laser System is intended for use in intraoral general dental surgery procedures, and in maxillofacial and cosmetic dentistry. It is intended for the incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue and a variety of hard tissues (tooth and bone).

AI/ML Overview

The provided document is a 510(k) premarket notification from the FDA for the LightMed Dental Laser System. It outlines the device's characteristics, its comparison to a predicate device, and compliance with various standards. However, it does not contain information on acceptance criteria for a study, nor does it describe a study proving the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device and compliance with safety and performance standards, rather than presenting results from an independent study on specific performance metrics with acceptance criteria.

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.