Cleared Traditional

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens

K230910 · Acculens, Inc. · Ophthalmic
Jun 2023
Decision
77d
Days
Class 2
Risk

About This 510(k) Submission

K230910 is an FDA 510(k) clearance for the NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Acculens, Inc. (Lakewood, US). The FDA issued a Cleared decision on June 16, 2023, 77 days after receiving the submission on March 31, 2023. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.

Submission Details

510(k) Number K230910 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2023
Decision Date June 16, 2023
Days to Decision 77 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

Device Classification

Product Code HQD — Lens, Contact (other Material) - Daily
Device Class Class II — Special Controls
CFR Regulation 21 CFR 886.5916

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