FDA.reportPublic FDA data

The Oligio

Primary DI
08800022305310
Brand
The Oligio
Company
WONTECH CO.,LTD
Model
The Oligio
Device description
Radio Frequency Therapy System
Published
2023-02-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221989000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221989000The OligioWontech Co., Ltd.2022-10-13GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800022305310PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800022305310088000223053108800022305310

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin contouring systemAn assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695658263
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800022304108SANDRO DualSANDRO Dual2020-06-16
08800022304412PICOALEXPICOALEX2025-03-25
08800022300803PastellePastelle2017-08-16
08800022304405PicowonPicowon2020-10-06
08800022300209Cosjet SRCosjet SR2017-08-16
08800022305327Oligio XOligio X2024-03-21
08800022304016ALMA VEIL; V-LaserALMA VEIL; V-Laser2023-08-24
08800022301404VeincareVeincare2024-12-17
08800022301800WONTECH Surgical Optic FibersBA4002025-02-24
08800022301817WONTECH Surgical Optic FibersBA6002025-02-24
08800022301824WONTECH Surgical Optic FibersBA400R2025-02-24
08800022301831WONTECH Surgical Optic FibersBA600R2025-02-24
08800022302906Pastelle ProPastelle Pro2025-02-24
08800022301121NOUVADermNOUVADerm2024-10-04
08800022301107LavieenLavieen2023-09-20
08800022305600PICOCAREMAJESTYPICOCAREMAJESTY2022-02-01
08800022305914PICOANDYPICOANDY2024-03-21
08800022304009V-LaserV-Laser2019-05-21
08800022304924Hair Boom69, Hair Beam Air, Hair Boom, Hair Boom Air, Ulike Hair UpUpHair Boom69, Hair Beam Air, Hair Boom, Hair Boom A2019-10-28
08800022303620Air Gap FiberAG2752024-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776428006MillenniumAvalign Technologies, Inc.GEI2026-08-27
00190776428037MillenniumAvalign Technologies, Inc.GEI2026-08-27
B4193533010Maxtown MedicalModern Surgical Instruments LLCGEI2026-08-27
ESUMARS980010SutterSutter Medizintechnik GmbHGEI2026-08-27
00190776427436MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427542MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427573MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427672MillenniumAvalign Technologies, Inc.GEI2026-08-26
00190776427689MillenniumAvalign Technologies, Inc.GEI2026-08-26
B108890POAMUS00BTL-890UBTL INDUSTRIES LIMITEDGEI2026-08-26
00841019123928KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-22
00190776427153MillenniumAvalign Technologies, Inc.GEI2026-08-21
B382SD83042110011NS0Surgical DirectSurgical Direct, Inc.GEI2026-08-21
00190776426675MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426729MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426781MillenniumAvalign Technologies, Inc.GEI2026-08-19
00841019123713KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123720KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123737KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123744KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019124154KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00190776414733MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776415310MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425890MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425913MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425920MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425937MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425944MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425951MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426354MillenniumAvalign Technologies, Inc.GEI2026-08-18