The following data is part of a premarket notification filed by Tti Medical with the FDA for Accu-beam C02 Laser Handpiece.
| Device ID | K945648 |
| 510k Number | K945648 |
| Device Name: | ACCU-BEAM C02 LASER HANDPIECE |
| Classification | Powered Laser Surgical Instrument |
| Applicant | TTI MEDICAL 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Contact | Allen R Howes |
| Correspondent | Allen R Howes TTI MEDICAL 7026 KOLL CENTER PKWY. SUITE 207 Pleasanton, CA 94566 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-17 |
| Decision Date | 1995-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B177620210 | K945648 | 000 |
| B17761040 | K945648 | 000 |
| B17761050 | K945648 | 000 |
| B17761080 | K945648 | 000 |
| B17761500 | K945648 | 000 |
| B17761510 | K945648 | 000 |
| B17762000 | K945648 | 000 |
| B177620020 | K945648 | 000 |
| B17762010 | K945648 | 000 |
| B177620110 | K945648 | 000 |
| B17762020 | K945648 | 000 |
| B17761030 | K945648 | 000 |