← FDA DEVICE PRODUCT CODES

FDA PRODUCT CODE · CLASS I

MSS — Folders And Injectors, Intraocular Lens (Iol)

DEVICE CLASS
Class I
REGULATION
21 CFR 886.4300
MEDICAL SPECIALTY
Ophthalmic
REVIEW PANEL
OP
— Implant— Life-sustaining— GMP-exempt✓ Third-party review eligible
3
510(K)/PMA CLEARANCES
510k: 3
0
RECALL ENTRIES

Recent clearances

K261174Rxsight, Inc. · 510k2026-06-10
K252540Medicel AG · 510k2025-09-16
K242389Bausch & Lomb, Incorporated · 510k2024-10-10

Related on SPEQ

Medical devices industry →Medical device quality (ISO 13485) →FDA device clearances →FDA enforcement & recalls →

Source: FDA device classification, 510(k)/PMA, and recall datasets (openFDA). Recall entries count distinct FDA recall numbers, so one recall event affecting several products appears as several entries. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data.

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