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 |