Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens— 510(k) K230965
Substantially EquivalentAcuity Polymers, Inc.
FDA 510(k) clearance K230965 for Acuity 100 (hexafocon A) with Tangible Hydra-PEG®, TYRO-97 (hofocon A) with Tangible Hydra-PEG® Rigid Gas Permeable Contact Lens, Substantially Equivalent on 2023-06-16. Applicant: Acuity Polymers, Inc.. Device class: 2.
Clearance details
- Applicant
- Acuity Polymers, Inc.
- Product code
- Code HQD
- Device class
- Class 2
- Regulation
- 21 CFR 886.5916
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
Recent devices under product code HQD
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- K241398 — SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses
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- K240618 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens +3 more
More clearances from Acuity Polymers, Inc.
view all- K213538 — Acuity 200 with Tangible Hydra-PEG (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
- K203571 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
- K201194 — Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
- K180988 — Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
- K170001 — Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens
Data sourced from openFDA. This site is unofficial and independent of the FDA.