LIGHTMED DENTAL TECHNOLOGY CORPORATION

Address:5F., NO. 96, LUKE 5TH RD., LUZHU DIST.,Kaohsiung City,TW

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Powered Laser Surgical Instrument (GEX) (2)

Premarket Exempt

Clear

LightMed - 04719882550010 Catalog Number : Saphhire

Device Description : LightMed Dental Laser System is intended to assist during dental procedures perf LightMed Dental Laser System is intended to assist during dental procedures performed in oral and maxillofacial surgery and dentistry. The Erbium YAG laser is indicated for a variety of hard tissue, soft tissue and bone applications. It is also indicated for incision, excision, cutting, ablation, vaporization, and coagulation of soft tissue in oral and maxillofacial surgery and dentistry.

Device Class : 2

Duns Number: 656103679

Premarket Exempt : No

Product Code : GEX

Prescription Use : No

Device Count : 1

LightMed - 04719882550034 Catalog Number : Sapphire