CANDELA URETHRAL/BLADDER SOUND— 510(k) K950633

Name: FDA 510(k) clearance K950633
Creator: U.S. Food and Drug Administration
Published: 1995-03-06

Substantially Equivalent

Candela Laser Corp.

FDA 510(k) clearance K950633 for CANDELA URETHRAL/BLADDER SOUND, Substantially Equivalent on 1995-03-06. Applicant: Candela Laser Corp.. Device class: 1.

Clearance details

Applicant: Candela Laser Corp.
Product code: Code FBX
Device class: Class 1
Regulation: 21 CFR 876.5520
Advisory panel: Gastroenterology, Urology
Date received: 1995-02-13
Decision date: 1995-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wayland, MA, US

Download summary PDF View on FDA.gov ↗

More clearances from Candela Laser Corp.

view all

K951033 — ANDELA DYNAMIC COOLING DEVICE1996-08-15
K955662 — CANDELA Q-SWITCHED ALEXANDRITE LASERS1996-06-14
K955011 — CANDELA HCS 2000 URETHERAL WARMER CATHETER1996-04-03
K954872 — CANDELA CRYO-PROBE HOLDER1996-02-05
K954934 — CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE1996-02-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.