The following data is part of a premarket notification filed by Dornier Medtech America, Inc. with the FDA for Dornier Sapphireerbium Handpiece, Dornier Sapphirespot Handpiece.
| Device ID | K011322 |
| 510k Number | K011322 |
| Device Name: | DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Contact | Brian Walsh |
| Correspondent | Brian Walsh DORNIER MEDTECH AMERICA, INC. 1155 ROBERTS BLVD. Kennesaw, GA 30144 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-01 |
| Decision Date | 2001-11-19 |