510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN230055Unknown

FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System

Balance Ophthalmics, Inc., Sioux Falls SD / Direct, Unknown
FDA source (opens on fda.gov)

DEN230055 is the FDA 510(k) clearance record for FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System, a class II device, cleared for Balance Ophthalmics, Inc. on under FDA product code QQJ (Applicator, Negative Pressure, External, Ocular). FDA's definition for product code QQJ reads: "External ocular negative pressure system. An external ocular negative pressure system uses hardware and software to create negative pressure in front of the eye to temporarily lower intraocular pressure in glaucoma patients". FDA records list 2 510(k) clearances for Balance Ophthalmics, Inc., from to . As of , FDA records show no recalls naming DEN230055.

Clearance record

Decision date
Received
(307 days to decision)
Product code
QQJ Applicator, Negative Pressure, External, Ocular
Regulation
21 CFR 886.5000
Device class
Class II
Review panel
Ophthalmic
Applicant
Balance Ophthalmics, Inc. 3101 W 57th St., Sioux Falls SD
Third party review
No

Clearances, product code QQJ

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