510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894513Substantially Equivalent

Diathron(r) Diathermy Unit

Intl. Ophthalmic Industries Corp., Weston MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894513 is the FDA 510(k) clearance record for DIATHRON(R) DIATHERMY UNIT, a class II device, cleared for Intl. Ophthalmic Industries Corp. on under FDA product code HJM (Transilluminator, Ac-Powered). FDA records list 6 510(k) clearances for Intl. Ophthalmic Industries Corp., from to . As of , FDA records show no recalls naming K894513.

Clearance record

Decision date
Received
(104 days to decision)
Product code
HJM Transilluminator, Ac-Powered
Regulation
21 CFR 886.1945
Device class
Class II
Review panel
Ophthalmic
Applicant
Intl. Ophthalmic Industries Corp. 54 Bay State Rd., Weston MA
Third party review
No

Clearances, product code HJM

Trailing 12 months

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

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