MSS
- Product code
- MSS
- Device name
- Folders And Injectors, Intraocular Lens (Iol)
- Device class
- Class 1
- 21 CFR
- 21 CFR 886.4300
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 63 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K261174 | 2026-06-10 | Rxsight, Inc. | RxSight® Insertion Device | |
| K252540 | 2025-09-16 | Medicel AG | ACCUJECT Injector Set 2.1-1P (LP604590) | |
| K242389 | 2024-10-10 | Bausch & Lomb, Incorporated | EyeGility Inserter for Preloaded enVista IOLs | |
| K231106 | 2023-09-19 | Medicel AG | Accuject Refra Injector AR2900 |
Official FDA classification page: MSS
Classification and pathway per current FDA publications. Data from openFDA (CC0).