510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K932930Substantially Equivalent

Candela Minibrush

Candela Corporation, Wayland MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K932930 is the FDA 510(k) clearance record for CANDELA MINIBRUSH, a class II device, cleared for Candela Laser Corp. on under FDA product code FEB (Accessories, Cleaning, For Endoscope). FDA's definition for product code FEB reads: "If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at...". FDA records list 99 510(k) clearances for Candela Corporation, from to . As of , FDA records show no recalls naming K932930.

Clearance record

Decision date
Received
(112 days to decision)
Product code
FEB Accessories, Cleaning, For Endoscope
Regulation
21 CFR 876.1500
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Candela Laser Corp. 530 Boston Post Rd., Wayland MA
510(k) summary
Summary
Third party review
No

Clearances, product code FEB

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