The following data is part of a premarket notification filed by Hoya Photonics, Inc. with the FDA for Diodent Ii Dental Laser System.
| Device ID | K050274 |
| 510k Number | K050274 |
| Device Name: | DIODENT II DENTAL LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | HOYA PHOTONICS, INC. 47733 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Jim Green |
| Correspondent | Jim Green HOYA PHOTONICS, INC. 47733 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-07 |
| Decision Date | 2005-04-29 |
| Summary: | summary |