FDA.reportPublic FDA data

AGNES

Primary DI
18800067700009
Brand
AGNES
Company
AGNES MEDICAL CO., LTD.
Model
AGNES
Device description
This is 1 set with following deviceAGNES: 1EA, GA-B: 10EA, GA-C: 10EA, GA-E: 10EA, GA-F1A: 10EA, GA-F1B: 10EA, GA-I: 10EA, GA-IL: 10EA, GA-S: 10EA, GA-SL: 10EAGA-W3A: 10EA, GA-F3A: 10EA, GA-W3B: 10EAAG-CN18G: 10EA, AG-CN19G: 10EA, AG-CN20G: 10EA, AG-CN21G: 10EA, AG-CN23G: 10EA
Published
2023-07-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
KCWEpilator, High Frequency, Needle-Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
KCWEpilator, High Frequency, Needle-TypeGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203013000AGNESAgnes Medical Co., Ltd.2022-07-14GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800067700009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1880006770000918800067700009

GMDN Terms#

Term, Definition table
TermDefinition
Intradermal radio-frequency ablation systemAn assembly of devices designed to apply radio-frequency (RF) energy to heat the dermal layer of the skin (e.g., the sebaceous glands) [invasive] for ablation (e.g., thermolysis) during an aesthetic procedure (e.g., acne treatment). It primarily consists of an electrically-powered control unit intended to produce and regulate the RF energy, and a connected monopolar RF applicator (probe) to deliver the RF energy to the skin; it may in addition include a bipolar (noninvasive) RF applicator.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity0 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+823180209717jglee@agnesmedical.com

Regulatory Flags#

DUNS number
987426048
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800067700026GA-CGA-C2023-07-14
08800067700033GA-IGA-I2023-07-14
08800067700040GA-EGA-E2023-07-14
08800067700057GA-SGA-S2023-07-14
08800067700064GA-W3AGA-W3A2023-07-14
08800067700071GA-F3AGA-F3A2023-07-14
08800067700088GA-BGA-B2023-07-14
08800067700095GA-ILGA-IL2023-07-14
08800067700101GA-SLGA-SL2023-07-14
08800067700118GA-F1AGA-F1A2023-07-14
08800067700125GA-W3BGA-W3B2023-07-14
08800067700132GA-F1BGA-F1B2023-07-14
08800067700170AG-CN18GAG-CN18G2023-07-14
08800067700187AG-CN19GAG-CN19G2023-07-14
08800067700194AG-CN20GAG-CN20G2023-07-14
08800067700200AG-CN21GAG-CN21G2023-07-14
08800067700217AG-CN23GAG-CN23G2023-07-14
08800067700248PlazMagikPlazMagik2026-04-16
08800067700378RO-25SRO-25S2026-04-17
08800067700385RO-25DRO-25D2026-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776405922MillenniumAvalign Technologies, Inc.GEI2026-07-26
00190776405939MillenniumAvalign Technologies, Inc.GEI2026-07-26
00841019123959KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123966KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123973KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123980KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00841019123997KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-25
00190776405809MillenniumAvalign Technologies, Inc.GEI2026-07-24
00841019123867KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-07-24
00198506092930ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506092947ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
00198506093234ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-22
04250418748346Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
04250418753722Guenter Bissinger Medizintechnik GmbHGünter Bissinger Medizintechnik GmbHGEI2026-07-21
08800020100481POTENZA TipJeisys Medical Inc.GEI2026-07-21
08800020101754POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101761POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020101778POTENZA HandpieceJeisys Medical Inc.GEI2026-07-21
08800020110541INTRAcel PremiumJeisys Medical Inc.GEI2026-07-21
00190776402143MillenniumAvalign Technologies, Inc.GEI2026-07-19
00198506092756ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
00198506092923ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-17
B382SD89239290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89509290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89529290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89759150Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89819320Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839280Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89839290Surgical DirectSurgical Direct, Inc.GEI2026-07-17
B382SD89914450Surgical DirectSurgical Direct, Inc.GEI2026-07-17