FDA product code MOE: Collagen Corneal Shield
MOE is the FDA product code for collagen corneal shield. It is a Class I device, regulated under 21 CFR 886.4750 and reviewed by the Ophthalmic panel. FDA has cleared 19 510(k) submissions under MOE, from 8 different applicants. The average 510(k) review took 127 days (median 87).
Classification
| Field | Value |
|---|---|
| Device name | Collagen Corneal Shield |
| Device class | Class I |
| Regulation | 21 CFR 886.4750 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every MOE clearance
Top MOE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Chiron Ophthalmics | 6 | 1992-03-06 |
| Bausch & Lomb Pharmaceutical, Inc. | 5 | 1990-02-09 |
| Vitaphore Corp. | 2 | 1991-10-15 |
| Bausch & Lomb, Inc. | 2 | 1988-01-22 |
| Bausch & Lomb Healthcare and Optics Worldwide | 1 | 1995-07-26 |
3 more applicants have MOE clearances. See the full list in Caduvo.
Most recent MOE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K944872 | Bausch & Lomb Healthcare and Optics Worldwide | BIO-COR COLLAGEN CORNEAL SHIELD | 1995-07-26 | 296 |
| K915861 | Chiron Ophthalmics | MEDILENS-CS CORNEAL SHIELD | 1992-03-06 | 66 |
| K914529 | Oasis Medical, Inc. | SOFTSHIELD(TM) 12, 24, 72 COLLAGEN CORNEAL SHIELDS | 1991-11-13 | 33 |
| K913148 | Vitaphore Corp. | COLLAGEN SHIELD FOR ACUTE CARE | 1991-10-15 | 91 |
| K905825 | Chiron Ophthalmics | COLLAGEN SHIELD, VARIOUS MODELS | 1991-06-10 | 161 |
Recalls for MOE devices
openFDA lists no recalls for product code MOE.
Frequently asked questions
What is FDA product code MOE?
MOE is the FDA product code for collagen corneal shield. It is a Class I device, regulated under 21 CFR 886.4750 and reviewed by the Ophthalmic panel.
What device class is MOE?
Class I, regulation 21 CFR 886.4750. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MOE?
Across 19 cleared submissions the average was 127 days from receipt to decision (median 87).
Which companies have the most MOE clearances?
Chiron Ophthalmics (6); Bausch & Lomb Pharmaceutical, Inc. (5); Vitaphore Corp. (2); Bausch & Lomb, Inc. (2); Bausch & Lomb Healthcare and Optics Worldwide (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MOE
- Run a recall and safety report across every MOE manufacturer
- Watch product code MOE 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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