The following data is part of a premarket notification filed by Technolas Perfect Vision Gmbh with the FDA for Femtec Laser System For Capsulotomy.
| Device ID | K110427 |
| 510k Number | K110427 |
| Device Name: | FEMTEC LASER SYSTEM FOR CAPSULOTOMY |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | TECHNOLAS PERFECT VISION GMBH PO BOX 17190 Anaheim, CA 92817 -7190 |
| Contact | Betty M Johnson |
| Correspondent | Betty M Johnson TECHNOLAS PERFECT VISION GMBH PO BOX 17190 Anaheim, CA 92817 -7190 |
| Product Code | OOE |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-14 |
| Decision Date | 2011-11-22 |
| Summary: | summary |