NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens— 510(k) K230910
Substantially EquivalentAcculens, Inc.
FDA 510(k) clearance K230910 for NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens, Substantially Equivalent on 2023-06-16. Applicant: Acculens, Inc.. Device class: 2.
Clearance details
- Applicant
- Acculens, 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
- Lakewood, CO, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.