510(k) K230910— NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens

Substantially Equivalent

Acculens, Inc.

Clearance details

Applicant: Acculens, Inc.
Product code: Code HQD
Advisory panel: Ophthalmic
Date received: 2023-03-31
Decision date: 2023-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

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