CANDELA MODEL MDL-1 LASER LITHOTRIPTOR— 510(k) K863642

Name: FDA 510(k) clearance K863642
Creator: U.S. Food and Drug Administration
Published: 1986-12-03

Substantially Equivalent

Candela Corp.

FDA 510(k) clearance K863642 for CANDELA MODEL MDL-1 LASER LITHOTRIPTOR, Substantially Equivalent on 1986-12-03. Applicant: Candela Corp.. Device class: 2.

Clearance details

Applicant: Candela Corp.
Product code: Code FFK
Device class: Class 2
Regulation: 21 CFR 876.4480
Advisory panel: Gastroenterology, Urology
Date received: 1986-09-17
Decision date: 1986-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Natick, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code FFK

view all

K242888 — Electrohydraulic Lithotriptor (TCS-B3-II)2025-03-21
K243032 — EHL Probe (3 models)2025-03-21
K230488 — EL27-Compact; Sterile EHL-Probes2023-08-31
K202813 — URO-TOUCH 9 French Probe2021-06-14
K191124 — Swiss LithoClast Trilogy2019-05-29

More clearances from Candela Corp.

view all

K183452 — Vbeam Prima Laser System2019-02-01
K140732 — CANDELA GENTLELASE FAMILY OF LASER SYSTEMS2014-11-07
K140122 — CANDELA GENTLEMAX FAMILY OF LASER SYSTEM2014-05-09
K133283 — CANDELA GENTLEMAX FAMILY OF LASER SYSTEMS2013-12-26
K112715 — CANDELA GENTLEMAX FAMILY OF LASERS2011-10-05

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