LightMed Dental Laser System

Lightmed Dentaltechnology Corp.

Country / region:Taiwan (TW)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number
K170073
Device name
LightMed Dental Laser System
Country / region
Taiwan(TW)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2017-01-09
Decision date
2017-07-25
Submission type
Traditional
Technology type
Er:YAG(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

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). 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
* Gingivoplasties
* 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, hyperplasia, epulides, 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

Intended Use

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). 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, Gingivoplasties, 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, hyperplasia, epulides, 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.

Summary parsed at:2026-06-01 05:59:26 UTC

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