510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K921163Substantially Equivalent

Regaltech Maxiscope

Regaltech Pty., Ltd., Western Australia, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921163 is the FDA 510(k) clearance record for REGALTECH MAXISCOPE, a class II device, cleared for Regaltech Pty. , Ltd. on under FDA product code HLI (Ophthalmoscope, Ac-Powered). FDA records list one 510(k) clearance for Regaltech Pty. , Ltd. As of , FDA records show no recalls naming K921163.

Clearance record

Decision date
Received
(230 days to decision)
Product code
HLI Ophthalmoscope, Ac-Powered
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Applicant
Regaltech Pty. , Ltd. 12 Princes St., Western Australia, AU
510(k) summary
Statement
Third party review
No

Clearances, product code HLI

Trailing 12 months

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

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