SINGLE AMPLIFIER FOR BOTOX— 510(k) K051852

Substantially Equivalent

Allergan, Inc.

FDA 510(k) clearance K051852 for SINGLE AMPLIFIER FOR BOTOX, Substantially Equivalent on 2005-09-14. Applicant: Allergan, Inc.. Device class: 2.

Clearance details

Applicant: Allergan, Inc.
Product code: Code GWL
Device class: Class 2
Regulation: 21 CFR 882.1835
Advisory panel: Neurology
Date received: 2005-07-08
Decision date: 2005-09-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GWL

K243746 — Delphi Amplifier2025-03-12
K242832 — NExT Station; NExT Station Advanced2024-12-12
K240646 — DreamClear2024-09-04
K242305 — BE Plus PRO, Neurotravel LIGHT2024-09-04
K232210 — X-trodes System M2024-02-04

More clearances from Allergan, Inc.

K190674 — REFRESH RELIEVA For CONTACTS2019-08-08
K161457 — XEN Glaucoma Treatment System2016-11-21
K143354 — Natrelle 133 Plus Tissue Expander2015-08-20
K083812 — REFRESH OPTIVE LENS COMFORT REWETTING DROPS2009-07-09
K014202 — COMPLETE BRAND MULTI-PURPOSE SOLUTION2002-02-20

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