FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RxSight® Insertion Device
K Number: K261174
·
Decision Jun 10, 2026
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
62
Applicant Total
6
Review Days
62
Basic Information
- Device Name
- RxSight® Insertion Device
- K Number
- K261174
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Rxsight, Inc.
- Date Received
- April 9, 2026
- Decision Date
- June 10, 2026
- Product Code
- MSS
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MSS | Folders And Injectors, Intraocular Lens (Iol) | FDA class 1 | Ophthalmic |
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Other Clearances by Rxsight, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K231838 | RxSight® Insertion Device (63002) | Aug 15, 2023 | Substantially Equivalent |
| K231466 | RxSight Insertion Device | Jun 12, 2023 | Substantially Equivalent |
| K201909 | RxSight Contact Lens | Sep 10, 2020 | Substantially Equivalent |
| K192926 | RxSight Insertion Device | Jan 17, 2020 | Substantially Equivalent |
| K181401 | RxSight Insertion Device | Jul 26, 2018 | Substantially Equivalent |