510(k) K183167
- Device
- Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens
- Applicant
- Bausch & Lomb, Incorporated
- 510(k) number
- K183167
- Product code
- HQD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2019-02-12
- Date received
- 2018-11-15
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Glenn A. Davies
- Address
- 1400 N. Goodman St. Rochester NY US 14609 14609
FDA Registration Numbers#
- 3005147469
- 3001190611
- 3014964775
- 9612500
- 1000123221
- 1835957
- 3012228452
- 3003357577
- 3025308027
- 2030598
- 3014769028
- 3013398957
- 2031102
- 3032010300
- 3005994941
- 1313525
- 3005087645
- 3014175039
- 3022320387
- 3006204913
- 3033524682
- 3002830597
- 3022988037
- 9681630
- 1281950
- 3043365583
- 1720959
- 9614761
- 3003062331
- 1065845
- 3020246591
- 3010607087
- 1123818
- 3012719596
Source Documents#
Other 510(k) Records For Product Code HQD #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253822 | GPA (hexafocon A) Rigid Gas Permeable Contact Lenses | Zhuhai Fitlens Medical Technology Co., Ltd. | 2026-03-27 |
| K242393 | Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses | Acuity Polymers, Inc. | 2024-11-01 |
| K241398 | SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses | Tianjin Mastervision Technology Co., Ltd. | 2024-10-22 |
| K241571 | BostonSight® Specialty Lenses | Boston Foundation For Sight, Inc. D/B/A Bostonsight | 2024-08-14 |
| K240618 | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2024-04-03 |
| K233325 | Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A) | Visionary Optics, LLC | 2024-02-21 |
| K230965 | Acuity 100™ (hexafocon A) with Tangible™ Hydra-PEG®, TYRO™-97 (hofocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lens | Acuity Polymers, Inc. | 2023-06-16 |
| 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 |
Legacy Summary#
summary