The following data is part of a premarket notification filed by Lightmed Dentaltechnology Corp. with the FDA for Lightmed Dental Laser System.
| Device ID | K170073 |
| 510k Number | K170073 |
| Device Name: | LightMed Dental Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LIGHTMED DENTALTECHNOLOGY CORP. 5F., NO. 96, LUKE 5TH RD., LUZHU DIST. Kaohsiung, TW 821 |
| Contact | April Cheng |
| Correspondent | April Cheng LIGHTMED DENTALTECHNOLOGY CORP. 5F., NO. 96, LUKE 5TH RD., LUZHU DIST. Kaohsiung, TW 821 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-09 |
| Decision Date | 2017-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719882550010 | K170073 | 000 |
| 04719882550034 | K170073 | 000 |