510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150722Substantially Equivalent

EnFocus 2300, EnFocus 4400

Bioptigen, Inc., Morrisville NC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150722 is the FDA 510(k) clearance record for EnFocus 2300, EnFocus 4400, a class II device, cleared for Bioptigen, Inc. on under FDA product code HLI (Ophthalmoscope, Ac-Powered). FDA records list 4 510(k) clearances for Bioptigen, Inc., from to . As of , FDA records show no recalls naming K150722.

Clearance record

Decision date
Received
(257 days to decision)
Product code
HLI Ophthalmoscope, Ac-Powered
Regulation
21 CFR 886.1570
Device class
Class II
Review panel
Ophthalmic
Applicant
Bioptigen, Inc. 633 Davis Dr., Morrisville NC
510(k) summary
Summary PDF
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