Panels › Ophthalmic › Product code MUW · Class 2
Lens, Contact (Orthokeratology)
Regulation 886.5916
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in MUW
| Company | 510(k)s | Recalls |
|---|---|---|
| Paragon Vision Sciences | 2 | 0 |
| Airperm, Inc. | 1 | 0 |
| C&E GP Specialist, Inc. | 1 | 0 |
| Contamac, Ltd. | 1 | 0 |
| Polymer Technology | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 9, 2019 | K183200 | iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses C&E GP Specialist, Inc. | MUW |
| Jul 13, 2016 | K160859 | OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E) Contamac, Ltd., GB | MUW |
| Feb 28, 2001 | K010109 | FLUOROPERM 151-OK, PARAGON HDS 100-OK Paragon Vision Sciences | MUW |
| Feb 16, 2001 | K003933 | BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY Polymer Technology | MUW |
| Apr 17, 2000 | K000224 | FLUROPERM 60-OK, PARAGON HDS-OK Paragon Vision Sciences | MUW |
| Apr 8, 1998 | K973697 | AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY Airperm, Inc. | MUW |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.