FDA product code MUW: Lens, Contact (Orthokeratology)
MUW is the FDA product code for lens, contact (orthokeratology). It is a Class II device, regulated under 21 CFR 886.5916 and reviewed by the Ophthalmic panel. FDA has cleared 6 510(k) submissions under MUW, from 5 different applicants. The average 510(k) review took 90 days (median 71). 1 PMA application cites this product code.
Classification
| Field | Value |
|---|---|
| Device name | Lens, Contact (Orthokeratology) |
| Device class | Class II |
| Regulation | 21 CFR 886.5916 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) |
510(k) clearances per year for MUW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 51 |
Compare with all 510(k) review times · Search every MUW clearance
Top MUW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Paragon Vision Sciences | 2 | 2001-02-28 |
| C&E GP Specialist, Inc. | 1 | 2019-01-09 |
| Contamac, Ltd. | 1 | 2016-07-13 |
| Polymer Technology | 1 | 2001-02-16 |
| Airperm, Inc. | 1 | 1998-04-08 |
Most recent MUW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K183200 | C&E GP Specialist, Inc. | iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses | 2019-01-09 | 51 |
| K160859 | Contamac, Ltd. | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) | 2016-07-13 | 106 |
| K010109 | Paragon Vision Sciences | FLUOROPERM 151-OK, PARAGON HDS 100-OK | 2001-02-28 | 47 |
| K003933 | Polymer Technology | BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY | 2001-02-16 | 58 |
| K000224 | Paragon Vision Sciences | FLUROPERM 60-OK, PARAGON HDS-OK | 2000-04-17 | 84 |
Recalls for MUW devices
openFDA lists no recalls for product code MUW.
Frequently asked questions
What is FDA product code MUW?
MUW is the FDA product code for lens, contact (orthokeratology). It is a Class II device, regulated under 21 CFR 886.5916 and reviewed by the Ophthalmic panel.
What device class is MUW?
Class II, regulation 21 CFR 886.5916. Typical premarket route: 510(k).
How long does a 510(k) take for product code MUW?
Across 6 cleared submissions the average was 90 days from receipt to decision (median 71).
Which companies have the most MUW clearances?
Paragon Vision Sciences (2); C&E GP Specialist, Inc. (1); Contamac, Ltd. (1); Polymer Technology (1); Airperm, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MUW
- Run a recall and safety report across every MUW manufacturer
- Watch product code MUW 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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