The following data is part of a premarket notification filed by Alcon Laboratories, Inc. with the FDA for Clareon Monarch Iv Iol Delivery System.
| Device ID | K212039 |
| 510k Number | K212039 |
| Device Name: | CLAREON MONARCH IV IOL Delivery System |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | ALCON LABORATORIES, INC. 6201 South Freeway Fort Worth, TX 76134 |
| Contact | Jwalitha Shankardas |
| Correspondent | Jwalitha Shankardas ALCON LABORATORIES,INC 6201 South Freeway Fort Worth, TX 76134 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-30 |
| Decision Date | 2021-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380659777745 | K212039 | 000 |