510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K830215Substantially Equivalent

Dorc Lightweight Binocular Ophthalmoscop

JEDMED Instrument Company, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830215 is the FDA 510(k) clearance record for DORC LIGHTWEIGHT BINOCULAR OPHTHALMOSCOP, a class II device, cleared for Jedmed Instrument Co. on under FDA product code HLJ (Ophthalmoscope, Battery-Powered). FDA records list 93 510(k) clearances for Jedmed Instrument Co., from to . As of , FDA records show no recalls naming K830215.

Clearance record

Decision date
Received
(44 days to decision)
Product code
HLJ Ophthalmoscope, Battery-Powered
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Applicant
Jedmed Instrument Co. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code HLJ

Trailing 12 months

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

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