510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063352Substantially Equivalent

Ellex Slit Lamp, Model 30Xl

Takagi Seiko Co., Ltd., Adelaide, South Australia, AU / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K063352 is the FDA 510(k) clearance record for ELLEX SLIT LAMP, MODEL 30XL, a class II device, cleared for Takagi Seiko Co., Ltd. on under FDA product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered). FDA records list 5 510(k) clearances for Takagi Seiko Co., Ltd., from to . As of , FDA records show no recalls naming K063352.

Clearance record

Decision date
Received
(127 days to decision)
Product code
HJO Biomicroscope, Slit-Lamp, Ac-Powered
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Applicant
Takagi Seiko Co., Ltd. 82 Gilbert St., Adelaide, South Australia, AU
510(k) summary
Statement
Third party review
No

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