The following data is part of a premarket notification filed by Bioptron Ag with the FDA for Bioptron Pro Light Therapy System And Bioptron Compact Iii Light Therapy System.
| Device ID | K032216 |
| 510k Number | K032216 |
| Device Name: | BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM |
| Classification | Powered Light Based Laser Non-thermal Instrument With Non-heating Effect For Adjunctive Use In Pain Therapy |
| Applicant | BIOPTRON AG 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls BIOPTRON AG 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | NHN |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-21 |
| Decision Date | 2004-02-04 |