FDA.reportPublic FDA data

Wavefacial

Primary DI
08809851470145
Brand
Wavefacial
Company
WEERO Co., Ltd.
Model
APQ-10M
Published
2026-06-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GZJStimulator, Nerve, Transcutaneous, For Pain Relief
IPFStimulator, Muscle, Powered
IRTPad, Heating, Powered
PBXMassager, Vacuum, Radio Frequency Induced Heat
QPZContact Cooling For Skin Lesion Pain Relief

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GZJStimulator, Nerve, Transcutaneous, For Pain ReliefNeurology2
IPFStimulator, Muscle, PoweredPhysical Medicine2
IRTPad, Heating, PoweredPhysical Medicine2
PBXMassager, Vacuum, Radio Frequency Induced HeatGeneral, Plastic Surgery2
QPZContact Cooling For Skin Lesion Pain ReliefGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253261000
K253542000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253261000Apollo Quattro (APQ-10M)Weero Co., Ltd.2026-03-13PBX
K253542000Apollo Quattro (APQ-10M)Weero Co., Ltd.2026-06-08IPF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809851470145PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809851470145088098514701458809851470145

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality physical therapy system, non-simultaneous, professional-useAn assembly of electrically-powered devices designed for professional use to apply multiple different energies (e.g., light-energy, ultrasound, radio-frequency electrical stimulation, electrotherapy) either alone or in sequence, but not simultaneously, to noninvasively treat/prevent a variety of soft-tissue, neuromuscular, and musculoskeletal injuries/disorders (e.g., joint pain/inflammation, stiffness, soft tissue injuries, muscle atrophy); it may in addition be used for aesthetic skin/body contouring (e.g., minimize cellulite, loose or wrinkled skin). It consists of a multi-modality control unit/generator, and dedicated applicators for the transcutaneous delivery of energy.

Regulatory Flags#

DUNS number
963224510
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809851470091EVE Synergy; EVE TitanEVE-20M2025-06-24
08809851470053eMVFitMVF-10M2024-10-22
08809851470060EVE Ace of FaceEVE-10002024-07-12
08809851470015Apollo Duet ADP-40002023-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712725359DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-09
06971712722693DOMASHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-09
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedGZJ2026-07-03
06971712727636ONENTECHHong Qiangxing (Shen Zhen) Electronics LimitedIPF2026-07-03
00810140063052RenphoJoicom CorporationIRT2026-06-23
00810140063069RenphoJoicom CorporationIRT2026-06-23
00810110200562BeurerBEURER NORTH AMERICA, L.P.IRT2026-06-09
00850087490177AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09
00850087490184AMOOSChangsha Yuhong Trading Co., LtdIRT2026-06-09
00041298995326DMID-M-S HOLDINGS, INC.IRT2026-06-05
G345SL2000CIONICCionic, Inc.IPF2026-06-04
00622356691161Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356699631Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356703048Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356704885Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356704953Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356710664Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356710718Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356712200Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356736633Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00840295411637TherabodyTherabody, Inc.IRT2026-06-01
00850298007072Monitoring Lead Wires, Set of 9SOMATICS, LLCGZJ2026-05-28
03770018808086actiTENSSUBLIMEDGZJ2026-05-27
03770018808086actiTENSSUBLIMEDIPF2026-05-27
03770018808093actiTENSSUBLIMEDGZJ2026-05-27
03770018808093actiTENSSUBLIMEDIPF2026-05-27
03770018808109actiTENSSUBLIMEDGZJ2026-05-27
03770018808109actiTENSSUBLIMEDIPF2026-05-27