| K-number | K945648 |
| Device name | ACCU-BEAM C02 LASER HANDPIECE |
| Applicant | Tti Medical |
| Product code | GEX |
| Device class | Class II |
| Decision date | Feb 24, 1995 |
| Decision | Substantially Equivalent |
| Regulation | 878.4810 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov