The following data is part of a premarket notification filed by Paradigm Medical Industries, Inc. with the FDA for Photon Multi-platform System, Model Z-12834-x & Z-13175-x.
| Device ID | K003318 |
| 510k Number | K003318 |
| Device Name: | PHOTON MULTI-PLATFORM SYSTEM, MODEL Z-12834-X & Z-13175-X |
| Classification | Powered Laser Surgical Instrument |
| Applicant | PARADIGM MEDICAL INDUSTRIES, INC. 2355 SOUTH 1070 WEST Salt Lake City, UT 84119 |
| Contact | Tracy S Best |
| Correspondent | Tracy S Best PARADIGM MEDICAL INDUSTRIES, INC. 2355 SOUTH 1070 WEST Salt Lake City, UT 84119 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-24 |
| Decision Date | 2001-05-22 |