The following data is part of a premarket notification filed by Bio-med Usa Inc. with the FDA for Lucid Ly.
| Device ID | K140837 |
| 510k Number | K140837 |
| Device Name: | LUCID LY |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BIO-MED USA INC. 27 NEW ENGLAND DRIVE Ramsey, NJ 07446 |
| Contact | Young Chi |
| Correspondent | Young Chi BIO-MED USA INC. 27 NEW ENGLAND DRIVE Ramsey, NJ 07446 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-02 |
| Decision Date | 2014-09-24 |
| Summary: | summary |