510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K820375Substantially Equivalent

Plastic or Glass Magnifier

Gazelle Corp., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K820375 is the FDA 510(k) clearance record for PLASTIC OR GLASS MAGNIFIER, a class I device, cleared for Gazelle Corp. on under FDA product code HJF (Magnifier, Hand-Held, Low-Vision). FDA records list 2 510(k) clearances for Gazelle Corp., from to . As of , FDA records show no recalls naming K820375.

Clearance record

Decision date
Received
(125 days to decision)
Product code
HJF Magnifier, Hand-Held, Low-Vision
Regulation
21 CFR 886.5540
Device class
Class I
Review panel
Ophthalmic
Applicant
Gazelle Corp. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HJF

Trailing 12 months

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

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