510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023221Substantially Equivalent

Contact Laser & Diagnostic Lenses

Volk Optical Inc, Rockville MD / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K023221 is the FDA 510(k) clearance record for CONTACT LASER & DIAGNOSTIC LENSES, a class II device, cleared for Volk Optical, Inc. on under FDA product code HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic). FDA records list 4 510(k) clearances for Volk Optical, Inc., from to . As of , FDA records show one recall naming K023221.

Clearance record

Decision date
Received
(14 days to decision)
Product code
HJK Lens, Contact, Polymethylmethacrylate, Diagnostic
Regulation
21 CFR 886.1385
Device class
Class II
Review panel
Ophthalmic
Applicant
Volk Optical, Inc. 15825 Shady Grove Rd.Suite 30, Rockville MD
510(k) summary
Statement
Third party review
No

Clearances, product code HJK

Trailing 12 months

FDA records hold no clearances under product code HJK in the trailing twelve months.

FDA records show no clearances under product code HJK in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HJK, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260