The following data is part of a premarket notification filed by The Yoshida Dental Mfg. Co., Ltd. with the FDA for Opelaser Pro Ii And The Opelaser Lite Ii.
| Device ID | K120932 |
| 510k Number | K120932 |
| Device Name: | OPELASER PRO II AND THE OPELASER LITE II |
| Classification | Powered Laser Surgical Instrument |
| Applicant | THE YOSHIDA DENTAL MFG. CO., LTD. 8870 RACELLO CT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm THE YOSHIDA DENTAL MFG. CO., LTD. 8870 RACELLO CT Naples, FL 34114 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-28 |
| Decision Date | 2012-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04547497771090 | K120932 | 000 |
| 04547497771052 | K120932 | 000 |