The following data is part of a premarket notification filed by Axiom Usa. Inc with the FDA for Axiom Biolaser Lllt Series-1.
| Device ID | K030622 |
| 510k Number | K030622 |
| Device Name: | AXIOM BIOLASER LLLT SERIES-1 |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | AXIOM USA. INC 3830 GUNN HWY Tampa, FL 33624 |
| Contact | James J Gibson |
| Correspondent | James J Gibson AXIOM USA. INC 3830 GUNN HWY Tampa, FL 33624 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-27 |
| Decision Date | 2003-09-09 |
| Summary: | summary |