The following data is part of a premarket notification filed by Lightmed Corp. with the FDA for Lightlas 561 Opthalmic Photocoagulator.
| Device ID | K063297 |
| 510k Number | K063297 |
| Device Name: | LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR |
| Classification | Laser, Ophthalmic |
| Applicant | LIGHTMED CORP. 437 HILLSIDE AVENUE Ben Lomond, CA 95005 |
| Contact | Dennis Dowell |
| Correspondent | Dennis Dowell LIGHTMED CORP. 437 HILLSIDE AVENUE Ben Lomond, CA 95005 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-01 |
| Decision Date | 2007-09-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04712826771014 | K063297 | 000 |