510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K082031Substantially Equivalent

Appasamy Slit Lamp, A1a-11 and A1a-12 Series

Appasamy Associates, Arumbakkam, Chennai, IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K082031 is the FDA 510(k) clearance record for APPASAMY SLIT LAMP, A1A-11 AND A1A-12 SERIES, a class II device, cleared for Appasamy Associates on under FDA product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered). FDA records list 2 510(k) clearances for Appasamy Associates, from to . As of , FDA records show no recalls naming K082031.

Clearance record

Decision date
Received
(14 days to decision)
Product code
HJO Biomicroscope, Slit-Lamp, Ac-Powered
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Applicant
Appasamy Associates 20, Sbi Officers Colony, Arumbakkam, Chennai, IN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code HJO

Trailing 12 months
2 clearances under product code HJO in the twelve months to October 2026, March 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HJO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20261
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260