The following data is part of a premarket notification filed by Kavo America with the FDA for Key Laser Iii 1243 Us With Detect.
| Device ID | K073074 |
| 510k Number | K073074 |
| Device Name: | KEY LASER III 1243 US WITH DETECT |
| Classification | Powered Laser Surgical Instrument |
| Applicant | KAVO AMERICA PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm KAVO AMERICA PO BOX 7007 Deerfield, IL 60015 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-31 |
| Decision Date | 2008-07-10 |
| Summary: | summary |