The following data is part of a premarket notification filed by Rxsight, Inc. with the FDA for Rxsight Contact Lens.
| Device ID | K201909 |
| 510k Number | K201909 |
| Device Name: | RxSight Contact Lens |
| Classification | Lens, Contact, Polymethylmethacrylate, Diagnostic |
| Applicant | RxSight, Inc. 100 Colombia Aliso Viejo, CA 92656 |
| Contact | Maureen O'connell |
| Correspondent | Maureen O'connell RxSight, Inc. 100 Colombia Aliso Viejo, CA 92656 |
| Product Code | HJK |
| CFR Regulation Number | 886.1385 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-09 |
| Decision Date | 2020-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818806020531 | K201909 | 000 |