The following data is part of a premarket notification filed by Alcon Laboratories with the FDA for Next Generation Laser.
| Device ID | K062624 |
| 510k Number | K062624 |
| Device Name: | NEXT GENERATION LASER |
| Classification | Laser, Ophthalmic |
| Applicant | ALCON LABORATORIES 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Contact | Terry J Dagnon |
| Correspondent | Terry J Dagnon ALCON LABORATORIES 6201 SOUTH FREEWAY Fort Worth, TX 76134 -2099 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-05 |
| Decision Date | 2007-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380657529872 | K062624 | 000 |
| 00380657514502 | K062624 | 000 |
| 00380657511907 | K062624 | 000 |
| 00380657510511 | K062624 | 000 |
| 00380657505975 | K062624 | 000 |
| 00380657515028 | K062624 | 000 |