FDA product code · Ophthalmic · Class 1
MSS: Folders And Injectors, Intraocular Lens (Iol)
MSS is FDA's product code for "Folders And Injectors, Intraocular Lens (Iol)": a Class 1 device classified under 21 CFR 886.4300, reviewed by the Ophthalmic panel.
510(k) review time for MSS
Across 13 510(k) clearances under MSS decided from 2018-01-01 to 2026-10-06, the median was 59 days from FDA receipt to decision. Half took between 54 and 93 days, and 80% were decided within 123 days. These are past clearances, not a forecast for a new submission.
| Fastest | 24 |
|---|---|
| 25th percentile | 54 |
| Median | 59 |
| 75th percentile | 93 |
| 80th percentile | 123 |
| 90th percentile | 151 |
| Slowest | 155 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
MSS in the public FDA record
| 510(k) clearances, all years | 63 |
|---|---|
| Establishment listings | 119 |
Counts of records, not of devices or events. Adverse event reports for MSS are in MAUDEScope, as counts with the query shown: MAUDE has no denominator, so a report count is not a rate and does not show that a device caused an event.
FDA-recognized standards that cite MSS
1 FDA recognized consensus standard cite MSS, among them ISO 11979-3 Third edition 2012-12-01. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 10-78 ISO 11979-3 Third edition 2012-12-01 — Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.