Duns Number:656103679
Device Description: LightMed Dental Laser System is intended to assist during dental procedures performed in o 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.
Catalog Number
Saphhire
Brand Name
LightMed
Version/Model Number
SA-108
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170073
Product Code
GEX
Product Code Name
Powered Laser Surgical Instrument
Public Device Record Key
bfb2ba0a-0041-40fa-b26c-38da88e5fe6b
Public Version Date
July 14, 2022
Public Version Number
2
DI Record Publish Date
March 20, 2021
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |