FDA.reportPublic FDA data

AGNES-S

Primary DI
08800067700019
Brand
AGNES-S
Company
AGNES MEDICAL CO., LTD.
Model
AGNES-S
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
KCWEpilator, High Frequency, Needle-Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCWEpilator, High Frequency, Needle-TypeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800067700019PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800067700019088000677000198800067700019

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
00686209051212ApilusDectro InternationalKCW2026-05-12
00667259003963EVOLUTION XHDSilhouet-Tone CorporationKCW2025-07-09
00667259003970EVOLUTION ST350Silhouet-Tone CorporationKCW2025-07-09
08800016903317Secret RF Smartcure Applicator With ElectrodesCLASSYS Inc.KCW2024-10-30
00686209051014Pro-TecDectro InternationalKCW2024-10-09
00686209051021Pro-TecDectro InternationalKCW2024-10-09
00686209051038Pro-TecDectro InternationalKCW2024-10-09
00686209051045Pro-TecDectro InternationalKCW2024-10-09
00686209051052Pro-TecDectro InternationalKCW2024-10-09
00686209052011Pro-TecDectro InternationalKCW2024-10-09
00686209052028Pro-TecDectro InternationalKCW2024-10-09
00686209052035Pro-TecDectro InternationalKCW2024-10-09
00686209052042Pro-TecDectro InternationalKCW2024-10-09
00686209052059Pro-TecDectro InternationalKCW2024-10-09
00686209052110Pro-TecDectro InternationalKCW2024-10-09
00686209052127Pro-TecDectro InternationalKCW2024-10-09
00686209052134Pro-TecDectro InternationalKCW2024-10-09
00686209052141Pro-TecDectro InternationalKCW2024-10-09
00686209052158Pro-TecDectro InternationalKCW2024-10-09
00686209100903ApilusDectro InternationalKCW2024-05-23
00686209100910ApilusDectro InternationalKCW2024-05-23
00686209101115ApilusDectro InternationalKCW2024-05-23
00686209106004ApilusDectro InternationalKCW2024-05-23
00686209106059ApilusDectro InternationalKCW2024-05-23
00686209101238ApilusDectro InternationalKCW2024-05-22
00850057194005Elegance+Clareblend, Inc.KCW2023-12-14
00850057194036EleganceClareblend, Inc.KCW2023-12-14
00850057194043G-TechClareblend, Inc.KCW2023-12-14
00850057194050EssenceClareblend, Inc.KCW2023-12-14
00850057194067EZ3Clareblend, Inc.KCW2023-12-14