The following data is part of a premarket notification filed by Industrial & Medical Design, Inc. with the FDA for Lucentlite, Model Imd 010.
| Device ID | K033072 |
| 510k Number | K033072 |
| Device Name: | LUCENTLITE, MODEL IMD 010 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | INDUSTRIAL & MEDICAL DESIGN, INC. 2570 CORPORATE PL., SUITE E104 Monterey Park, CA 91754 |
| Contact | Yevgeniy Kuklin |
| Correspondent | Yevgeniy Kuklin INDUSTRIAL & MEDICAL DESIGN, INC. 2570 CORPORATE PL., SUITE E104 Monterey Park, CA 91754 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-29 |
| Decision Date | 2004-04-01 |
| Summary: | summary |