510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950633Substantially Equivalent

Candela Urethral/bladder Sound

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

K950633 is the FDA 510(k) clearance record for CANDELA URETHRAL/BLADDER SOUND, a class I device, cleared for Candela Laser Corp. on under FDA product code FBX (Sound, Urethral, Metal Or Plastic). FDA records list 99 510(k) clearances for Candela Corporation, from to . As of , FDA records show no recalls naming K950633.

Clearance record

Decision date
Received
(21 days to decision)
Product code
FBX Sound, Urethral, Metal Or Plastic
Regulation
21 CFR 876.5520
Device class
Class I
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 FBX

Trailing 12 months

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

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