LMH · Implant, Dermal, For Aesthetic Use

· Class 3

Overview

Product Code	LMH
Device Name	Implant, Dermal, For Aesthetic Use
Device Class	Class 3
Review Panel
Implant	Yes

Record	Device Name	Applicant	Decision Date	Decision
P250020	Belotero Volume (+) Lidocaine	Merz North America, Inc.	May 19, 2026	APPR
P240008	saypha® MagIQ	Croma-Pharma GmbH	Sep 8, 2025	APPR
P240022	EVOLYSSE SMOOTH and EVOLYSSE FORM	Symatese	Feb 13, 2025	APPR
P170002	RHA 2, RHA 3, RHA 4	Teoxane S.A.	Oct 19, 2017	APPR
P160042	REVANESSE ULTRA	Prollenium Medical Technologies, Inc.	Aug 4, 2017	APPR
P140029	Restylane Refyne, Restylane Defyne	Q-Med AB	Dec 9, 2016	APPR
P110033	JUVEDERM VOLUMA XC	Allergan	Oct 22, 2013	APPR
P090016	BELOTERO BALANCE	Merz North America, Inc.	Nov 14, 2011	APPR
P070013	EVOLENCE COLLAGEN FILLER	Colbar Lifescience , Ltd.	Jun 27, 2008	APWD
P050052	RADIESSE INJECTABLE IMPLANT	Merz North America, Inc.	Dec 22, 2006	APPR
P050037	RADIESSE 1.3CC AND 0.3CC	Merz North America, Inc.	Dec 22, 2006	APPR
P050033	HYDRELLE	Anika Therapeutics, Inc.	Dec 20, 2006	APWD
P020012	ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER	Tiger Aesthetics Medical, LLC	Oct 27, 2006	APPR
P050047	JUVEDERM 24HV, JUVEDERM 30 AND JUVEDERM 30HV GEL IMPLANTS	Allergan	Jun 2, 2006	APPR
P040024	RESTYLANE INJECTABLE GEL	Q-Med AB	Mar 25, 2005	APPR
P030050	SCULPTRA AND SCULPTRA AESTHETIC	Q-Med AB	Aug 3, 2004	APPR
P030032	HYLAFORM (HYLAN B GEL)	Genzyme Biosurgery	Apr 22, 2004	APWD
P020023	RESTYLANE INJECTABLE GEL	Q-Med AB	Dec 12, 2003	APPR
P850053	FIBREL	Mentor Corp.	Feb 26, 1988	APWD
P800022	ZYDERM COLLAGEN IMPLANT (ZYDERM CI)	Allergan	Jul 22, 1981	APWD