510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K953030Substantially Equivalent

Slit Lamp Aia 11

Naveen Intl., Inc., Millersville MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K953030 is the FDA 510(k) clearance record for SLIT LAMP AIA 11, a class II device, cleared for Naveen Intl., Inc. on under FDA product code HJO (Biomicroscope, Slit-Lamp, Ac-Powered). FDA records list one 510(k) clearance for Naveen Intl., Inc. As of , FDA records show no recalls naming K953030.

Clearance record

Decision date
Received
(13 days to decision)
Product code
HJO Biomicroscope, Slit-Lamp, Ac-Powered
Regulation
21 CFR 886.1850
Device class
Class II
Review panel
Ophthalmic
Applicant
Naveen Intl., Inc. 193 Rock Ridge Rd., Millersville MD
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