FDA product code MSS: Folders And Injectors, Intraocular Lens (Iol)
MSS is the FDA product code for folders and injectors, intraocular lens (iol). It is a Class I device, regulated under 21 CFR 886.4300 and reviewed by the Ophthalmic panel. FDA has cleared 63 510(k) submissions under MSS, 6 in the last five years, from 28 different applicants. The average 510(k) review took 129 days (median 105); 52 days on average over the last three years. FDA has posted 5 recalls for MSS devices.
Classification
| Field | Value |
|---|---|
| Device name | Folders And Injectors, Intraocular Lens (Iol) |
| Device class | Class I |
| Regulation | 21 CFR 886.4300 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for MSS
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 67 |
| 2018 | 1 | 58 |
| 2019 | 3 | 92 |
| 2020 | 2 | 118 |
| 2021 | 1 | 54 |
| 2023 | 3 | 77 |
| 2024 | 1 | 59 |
| 2025 | 1 | 35 |
| 2026 | 1 | 62 |
Compare with all 510(k) review times · Search every MSS clearance
Top MSS applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Rxsight, Inc. | 5 | 2026-06-10 |
| Medicel AG | 5 | 2025-09-16 |
| Bausch & Lomb, Inc. | 5 | 2019-10-04 |
| Lenstec, Inc. | 5 | 2016-11-29 |
| Bausch & Lomb | 5 | 2014-01-09 |
23 more applicants have MSS clearances. See the full list in Caduvo.
Most recent MSS clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K261174 | Rxsight, Inc. | RxSight® Insertion Device | 2026-06-10 | 62 |
| K252540 | Medicel AG | ACCUJECT Injector Set 2.1-1P (LP604590) | 2025-09-16 | 35 |
| K242389 | Bausch & Lomb, Incorporated | EyeGility Inserter for Preloaded enVista IOLs | 2024-10-10 | 59 |
| K231106 | Medicel AG | Accuject Refra Injector AR2900 | 2023-09-19 | 153 |
| K231838 | Rxsight, Inc. | RxSight® Insertion Device (63002) | 2023-08-15 | 54 |
Recalls for MSS devices
5 product recalls in 5 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2020-03-17.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2020 | 1 |
Frequently asked questions
What is FDA product code MSS?
MSS is the FDA product code for folders and injectors, intraocular lens (iol). It is a Class I device, regulated under 21 CFR 886.4300 and reviewed by the Ophthalmic panel.
What device class is MSS?
Class I, regulation 21 CFR 886.4300. Typical premarket route: 510(k).
How long does a 510(k) take for product code MSS?
Across 63 cleared submissions the average was 129 days from receipt to decision (median 105).
Which companies have the most MSS clearances?
Rxsight, Inc. (5); Medicel AG (5); Bausch & Lomb, Inc. (5); Lenstec, Inc. (5); Bausch & Lomb (5).
Have MSS devices been recalled?
Yes: 5 product recalls across 5 recall events; the most recent began 2020-03-17.
Next steps
- Run an FDA pathway report with predicate devices for product code MSS
- Run a recall and safety report across every MSS manufacturer
- Watch product code MSS for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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