510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852054Substantially Equivalent

Contact Lens Loupe, Inspetion Loupe

Ascon Medical Instruments, Ltd., Westmont IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852054 is the FDA 510(k) clearance record for CONTACT LENS LOUPE, INSPETION LOUPE, a class I device, cleared for Ascon Medical Instruments, Ltd. on under FDA product code HLN (Gauge, Lens, Ophthalmic). FDA records list 6 510(k) clearances for Ascon Medical Instruments, Ltd., from to . As of , FDA records show no recalls naming K852054.

Clearance record

Decision date
Received
(119 days to decision)
Product code
HLN Gauge, Lens, Ophthalmic
Regulation
21 CFR 886.1420
Device class
Class I
Review panel
Ophthalmic
Applicant
Ascon Medical Instruments, Ltd. 825 N. Cass Ave., Suite 208, Westmont IL
Third party review
No

Clearances, product code HLN

Trailing 12 months

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

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