510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K050623Substantially Equivalent

Volk Disposable Vitrectomy Lenses, Models Volk Flat Ssv D, Volk Afx Ssv D, Volk 45 Prism Ssv D

Volk Optical Inc, Rockville MD / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K050623 is the FDA 510(k) clearance record for VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D, 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 K050623.

Clearance record

Decision date
Received
(18 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
Summary PDF
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