The following data is part of a premarket notification filed by Retinalabs.com with the FDA for Vertefusion-photodynamic Therapy Pak, Model 11000 Series; Photofusion-photodynamic Therapy Pak, Model 12000 Series.
| Device ID | K000457 |
| 510k Number | K000457 |
| Device Name: | VERTEFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 11000 SERIES; PHOTOFUSION-PHOTODYNAMIC THERAPY PAK, MODEL 12000 SERIES |
| Classification | Cannula, Ophthalmic |
| Applicant | RETINALABS.COM 1776 PEACHTREE ST. 200 NORTH Atlanta, GA 30309 |
| Contact | Frank Tighe |
| Correspondent | Frank Tighe RETINALABS.COM 1776 PEACHTREE ST. 200 NORTH Atlanta, GA 30309 |
| Product Code | HMX |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-11 |
| Decision Date | 2000-05-09 |