The following data is part of a premarket notification filed by Rxsight, Inc. with the FDA for Rxsight Insertion Device.
| Device ID | K181401 |
| 510k Number | K181401 |
| Device Name: | RxSight Insertion Device |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| 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 | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-29 |
| Decision Date | 2018-07-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10818806020019 | K181401 | 000 |
| 00818806020005 | K181401 | 000 |