510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K923656Substantially Equivalent

Lighting Source System

Galenica Enterprises, Inc., Quebec Canada J7e 4h7, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923656 is the FDA 510(k) clearance record for LIGHTING SOURCE SYSTEM, a class II device, cleared for Galenica Enterprises, Inc. on under FDA product code HIC (Speculum, Vaginal, Nonmetal, Fiberoptic). FDA records list 5 510(k) clearances for Galenica Enterprises, Inc., from to . As of , FDA records show no recalls naming K923656.

Clearance record

Decision date
Received
(787 days to decision)
Product code
HIC Speculum, Vaginal, Nonmetal, Fiberoptic
Regulation
21 CFR 884.4530
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Galenica Enterprises, Inc. C.p. 13, Quebec Canada J7e 4h7, CA
510(k) summary
Statement
Third party review
No

Clearances, product code HIC

Trailing 12 months

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

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