DISPOSABLE CYSTOTOME— 510(k) K831916
Substantially EquivalentCooperVision, Inc.
FDA 510(k) clearance K831916 for DISPOSABLE CYSTOTOME, Substantially Equivalent on 1983-07-12. Applicant: CooperVision, Inc.. Device class: 1.
Clearance details
- Applicant
- CooperVision, Inc.
- Product code
- Code HNY
- Device class
- Class 1
- Regulation
- 21 CFR 886.4350
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Southampton, GB
Recent devices under product code HNY
view allMore clearances from CooperVision, Inc.
view all- K234127 — Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker
- K220070 — MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
- K213164 — Avaira Vitality
- K202756 — Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day Multifocal (somofilcon A), Clariti 1 Day Multifocal Toric (somofilcon A)
- K191763 — MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC
Data sourced from openFDA. This site is unofficial and independent of the FDA.