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FDA 510(k)

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

K-Number: K230910 · 2023-06-16

ApplicantAcculens, Inc.
Decision Date2023-06-16
Product CodeHQD
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is a medical device manufactured by Acculens, Inc.. It received FDA 510(k) clearance on 2023-06-16 under approval number K230910. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens?

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is a medical device that received FDA 510(k) clearance on 2023-06-16. It is manufactured by Acculens, Inc.. The 510(k) number is K230910.

When was NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens approved by the FDA?

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens received FDA 510(k) clearance on 2023-06-16, under approval number K230910.

What company makes NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens?

NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is manufactured by Acculens, Inc..

What is the FDA product code for NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens?

The FDA product code for NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens is HQD.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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