510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230910Substantially Equivalent

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

Acculens, Inc., Lakewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230910 is the FDA 510(k) clearance record for NewVision SC (tisilfocon A) Scleral Lens; NewVision SC Daily Wear Ortho-K (tisilfocon A) Corneo-Scleral Lens, a class II device, cleared for Acculens, Inc. on under FDA product code HQD (Lens, Contact (Other Material) - Daily). FDA records list one 510(k) clearance for Acculens, Inc. As of , FDA records show no recalls naming K230910.

Clearance record

Decision date
Received
(77 days to decision)
Product code
HQD Lens, Contact (Other Material) - Daily
Regulation
21 CFR 886.5916
Device class
Class II
Review panel
Ophthalmic
Applicant
Acculens, Inc. 5353 W. Colfax Ave., Lakewood CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HQD

Trailing 12 months
1 clearance under product code HQD in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HQD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260