510(k) K160859
- Device
- OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)
- Applicant
- CONTAMAC LTD.
- 510(k) number
- K160859
- Product code
- MUW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-07-13
- Date received
- 2016-03-29
- Regulation
- 886.5916
- Classification name
- Lens, Contact (orthokeratology)
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROB MCGREGOR
- Address
- Carlton House Shire Hill Saffron Walden GB CB11 3AU CB11 3AU
FDA Registration Numbers#
- 1000123221
- 1281950
- 1835957
- 3043365583
- 1720959
- 3020246591
- 3012719596
- 3002830597
- 3022988037
- 3025308027
- 3014964775
- 1065845
- 2031102
- 9612500
- 3005147469
- 1313525
- 3001190611
Source Documents#
Other 510(k) Records For Product Code MUW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K183200 | iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses | C&E GP Specialist, Inc. | 2019-01-09 |
| K010109 | FLUOROPERM 151-OK, PARAGON HDS 100-OK | Paragon Vision Sciences | 2001-02-28 |
| K003933 | BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY | Polymer Technology | 2001-02-16 |
| K000224 | FLUROPERM 60-OK, PARAGON HDS-OK | Paragon Vision Sciences | 2000-04-17 |
| K973697 | AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY | Airperm, Inc. | 1998-04-08 |
Legacy Summary#
summary
FDA Review#
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