510(k) K231466

RxSight Insertion Device by Rxsight, Inc. — Product Code MSS

K231466 is an FDA 510(k) premarket notification submitted by Rxsight, Inc. for the device "RxSight Insertion Device". The FDA issued a decision of Substantially Equivalent on June 12, 2023. The device falls under product code MSS (Folders And Injectors, Intraocular Lens (Iol)), a Class I device regulated under 21 CFR 886.4300. Rxsight, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 12, 2023
Date Received
May 19, 2023
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Folders And Injectors, Intraocular Lens (Iol)
Device Class
Class I
Regulation Number
886.4300
Review Panel
OP
Submission Type