The following data is part of a premarket notification filed by Kavo America with the FDA for Gentleray 980 Diode Laser System.
| Device ID | K072262 |
| 510k Number | K072262 |
| Device Name: | GENTLERAY 980 DIODE LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
| Contact | John Miller |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-08-15 |
| Decision Date | 2007-10-26 |
| Summary: | summary |