The following data is part of a premarket notification filed by Axiom Usa. Inc with the FDA for Axiom Biolaser Lllt Series-3.
| Device ID | K033015 |
| 510k Number | K033015 |
| Device Name: | AXIOM BIOLASER LLLT SERIES-3 |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | AXIOM USA. INC 9423 CORPORATE LAKE DRIVE Tampa, FL 33634 |
| Contact | Jim Gibson |
| Correspondent | Jim Gibson AXIOM USA. INC 9423 CORPORATE LAKE DRIVE Tampa, FL 33634 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-26 |
| Decision Date | 2003-11-25 |
| Summary: | summary |