The following data is part of a premarket notification filed by Lucid, Inc. with the FDA for Vivascope System, Model 1500, 3000.
| Device ID | K080788 |
| 510k Number | K080788 |
| Device Name: | VIVASCOPE SYSTEM, MODEL 1500, 3000 |
| Classification | Light Based Imaging |
| Applicant | LUCID, INC. 2320 BRIGHTON HENRIETTA TOWNLINE RD Rochester, NY 14623 |
| Contact | James Joy |
| Correspondent | James Joy LUCID, INC. 2320 BRIGHTON HENRIETTA TOWNLINE RD Rochester, NY 14623 |
| Product Code | PSN |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-20 |
| Decision Date | 2008-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860292000306 | K080788 | 000 |