510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853035Substantially Equivalent

Hessburg Light Guard

Visitec Co., Sarasota FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853035 is the FDA 510(k) clearance record for HESSBURG LIGHT GUARD, a class I device, cleared for Visitec Co. on under FDA product code HOY (Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)). FDA records list 49 510(k) clearances for Visitec Co., from to . As of , FDA records show no recalls naming K853035.

Clearance record

Decision date
Received
(148 days to decision)
Product code
HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Regulation
21 CFR 886.4750
Device class
Class I
Review panel
Ophthalmic
Applicant
Visitec Co. 2043 Whitfield Park Dr., Sarasota FL
Third party review
No

Clearances, product code HOY

Trailing 12 months

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

FDA records show no clearances under product code HOY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HOY, 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