510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K092883Substantially Equivalent

LED Lamp or Other

Intravista Medical Systems, Inc., Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K092883 is the FDA 510(k) clearance record for LED LAMP OR OTHER, a class II device, cleared for Intravista Medical Systems, Inc. on under FDA product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered). FDA records list one 510(k) clearance for Intravista Medical Systems, Inc. As of , FDA records show no recalls naming K092883.

Clearance record

Decision date
Received
(91 days to decision)
Product code
HJO Biomicroscope, Slit-Lamp, Ac-Powered
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Applicant
Intravista Medical Systems, Inc. 1567 Samedra St., Sunnyvale CA
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