510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K822922Substantially Equivalent

5011 Ganzfeld Stimulator

Life-Tech Intl., Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822922 is the FDA 510(k) clearance record for 5011 GANZFELD STIMULATOR, a class II device, cleared for Life-Tech Intl., Inc. on under FDA product code HLX (Photostimulator, Ac-Powered). FDA records list 68 510(k) clearances for Life-Tech Intl., Inc., from to . As of , FDA records show no recalls naming K822922.

Clearance record

Decision date
Received
(88 days to decision)
Product code
HLX Photostimulator, Ac-Powered
Regulation
21 CFR 886.1630
Device class
Class II
Review panel
Ophthalmic
Applicant
Life-Tech Intl., Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HLX

Trailing 12 months

FDA records hold no clearances under product code HLX in the trailing twelve months.

FDA records show no clearances under product code HLX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HLX, 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