HomeUSAZELTIQ AESTHETICS, INC.

ZELTIQ AESTHETICS, INC.

USA · Pleasanton
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea, Australia, Hong Kong, Israel, Russia — 9 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
2listed device types
Class I 1Class II 1Class III 0
plus 39 registration records and 18 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
2 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
8active ARTG entries
Class I 4IIa 2IIb 2
HKHong KongMDACS
1valid listings
Class II 1
ILIsraelAMAR
4registrations
RURussiaRoszdravnadzor
3active registrations
Class 2a 3
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States39 registration records, 18 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: ZELTIQ AESTHETICS, INC. · Zeltiq Aesthetics Inc · ZELTIQ AESTHETICS INC. · ZELTIQ AESTHETICS INC

Company information

Country
USA
City
Pleasanton

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12008
12009
12010
12012
12014
22015
22016
22017
12018
12019
12020
12021
12022
22024

FDA listed device types

Dermal Cooling Pack/Vacuum/Massager 1Brush, Dermabrasion, Powered 1

Registration details (sample)

MarketIdentifierNameClass / date
USK233732CoolSculpting Elite System2024-09-12
USK233804Resonic Rapid Acoustic Pulse Device2024-02-01
USK222629Resonic Rapid Acoustic Pulse Device2022-09-25
BR82664449001Sistema de Aquecimento e Resfriamento – Sistema CoolSculpting®Class II

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