The following data is part of a premarket notification filed by Lensar, Inc. with the FDA for Ally Adaptive Cataract Treatment System.
Device ID | K220259 |
510k Number | K220259 |
Device Name: | ALLY Adaptive Cataract Treatment System |
Classification | Ophthalmic Femtosecond Laser |
Applicant | Lensar, Inc. 2800 Discovery Drive, Suite 100 Orlando, FL 32826 |
Contact | Keith Peck |
Correspondent | Keith Peck Lensar, Inc. 2800 Discovery Drive, Suite 100 Orlando, FL 32826 |
Product Code | OOE |
CFR Regulation Number | 886.4390 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-01-31 |
Decision Date | 2022-06-09 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10867744000157 | K220259 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() ALLY ADAPTIVE CATARACT TREATMENT SYSTEM 90759319 not registered Live/Pending |
Lensar, Inc. 2021-06-07 |