510(k) K010454
- Device
- THE ALBERTA LENS SM2, SULFOCON B
- Applicant
- Progressive Optical Research , Ltd.
- 510(k) number
- K010454
- Product code
- HQD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-08-01
- Date received
- 2001-02-15
- Regulation
- 886.5916
- Classification name
- Lens, Contact (Other Material) - Daily
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- NICK NOVICKY
- Address
- #20, 1410-40th Ave., NE Calgary, Alberta CA T2E 6L1 T2E 6L1
FDA Registration Numbers#
- 3010607087
- 3012719596
- 9614761
- 3005147469
- 3013398957
- 3014175039
- 3006204913
- 2030598
- 3002830597
- 3032010300
- 3014964775
- 3022988037
- 3005087645
- 2031102
- 3001190611
- 1000123221
- 1123818
- 1720959
- 9681630
- 3025308027
- 3033524682
- 1065845
- 3022320387
- 1313525
- 1281950
- 1835957
- 3014769028
- 3043365583
- 3003062331
- 3020246591
- 3005994941
- 9612500
- 3012228452
- 3003357577
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HQD#
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| K230910 | NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens | Acculens, Inc. | 2023-06-16 |
| K221768 | Oxfore®100 (hexafocon A) Rigid Gas Permeable Contact Lenses | Paragon Vision Sciences, Inc. | 2023-05-05 |
| K223394 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A) | Visionary Optics, LLC | 2022-12-07 |
| K212631 | Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses | Contamac, Ltd. | 2022-03-17 |
| K213880 | Custom Stable Rigid Gas Permeable Scleral Contact Lens | Valley Contax, Inc. | 2022-01-07 |
| K213538 | Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2021-12-30 |
| K202860 | Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax Goldeneye Aspheric Front Multifocal (AFM) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A), Valley Contax V Kone (VK) Gas Permeable Contact Lens (roflufocon D, roflufocon E, tisilfocon A, hexafocon A, enflufocon A) | Valley Contax, Inc. | 2021-05-11 |
| K203571 | Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2021-04-09 |