510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001111Substantially Equivalent

Panoret, Model 1000A

CMT Medical Technologies, Ltd., Haifa, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K001111 is the FDA 510(k) clearance record for PANORET, MODEL 1000A, a class II device, cleared for Cmt Medical Technologies, Ltd. on under FDA product code HKL (Retinoscope, Ac-Powered). FDA records list 12 510(k) clearances for Cmt Medical Technologies, Ltd., from to . As of , FDA records show no recalls naming K001111.

Clearance record

Decision date
Received
(92 days to decision)
Product code
HKL Retinoscope, Ac-Powered
Regulation
21 CFR 886.1780
Device class
Class II
Review panel
Ophthalmic
Applicant
Cmt Medical Technologies, Ltd. Matam High Technology Center, Haifa, IL
510(k) summary
Summary
Third party review
No

Clearances, product code HKL

Trailing 12 months

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

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