The following data is part of a premarket notification filed by Rxsight, Inc. with the FDA for Rxsight Insertion Device.
Device ID | K192926 |
510k Number | K192926 |
Device Name: | RxSight Insertion Device |
Classification | Folders And Injectors, Intraocular Lens (iol) |
Applicant | RxSight, Inc. 100 Columbia Aliso Viejo, CA 92656 |
Contact | Maureen O'connell |
Correspondent | Maureen O'connell RxSight, Inc. 100 Columbia 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 | 2019-10-16 |
Decision Date | 2020-01-17 |