FDA.reportPublic FDA data

PlazMagik

Primary DI
08800067700248
Brand
PlazMagik
Company
AGNES MEDICAL CO., LTD.
Model
PlazMagik
Device description
PlazMagik is an electro-surgical device for use in dermatological applications
Published
2026-04-16
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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K230837000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K230837000PlazMagikAgnes Medical Co., Ltd.2024-02-29GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800067700248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800067700248088000677002488800067700248

GMDN Terms#

Term, Definition table
TermDefinition
Plasma surgical systemAn assembly of electrically-powered devices designed to generate a fine plasma jet used to coagulate, cut, and/or vaporize/ablate tissue and/or reduce inflammation/promote healing during open, laparoscopic or topical surgery. The system has a gas [e.g., argon (Ar)] supply or an ambient air input, and typically includes a control unit, a handpiece(s) with connection cable and foot-switch. The plasma [e.g., argon (Ar), nitric oxide] is generated in the handpiece and is applied to tissue where the surgical effect is achieved without passing electric current through the body.

Storage And Handling#

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

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
08800067700378RO-25SRO-25S2026-04-17
08800067700385RO-25DRO-25D2026-04-17
08800067700392RO-25S(G)RO-25S(G)2026-04-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424527MillenniumAvalign Technologies, Inc.GEI2026-08-07
00841019123935KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
00841019123942KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
07613327548235NeptuneSTRYKER CORPORATIONGEI2026-08-07
08800017100920VIVACE Microneedle Cartridgeshenb Co., Ltd.GEI2026-08-07
00190776408718MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422677MillenniumAvalign Technologies, Inc.GEI2026-08-03
00190776422820MillenniumAvalign Technologies, Inc.GEI2026-08-03
B382SD5657815600Surgical DirectSurgical Direct, Inc.GEI2026-08-03
00190776407445MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422332MillenniumAvalign Technologies, Inc.GEI2026-07-31
00190776422516MillenniumAvalign Technologies, Inc.GEI2026-07-31
00198506092640ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
00198506093562ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-29
07613327688849MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688856MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688979MalisSTRYKER CORPORATIONGEI2026-07-29
07613327688986MalisSTRYKER CORPORATIONGEI2026-07-29
08800020110688INTRAGen HandpieceJeisys Medical Inc.GEI2026-07-29
B354OSRP80Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP81Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP82Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP83Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP84Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP85Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
B354OSRP89Retrieval Pouch (Multi Deploy) 8 mmORANGE SURGICAL INSTRUMENTS, LLCGEI2026-07-29
00190776407285MillenniumAvalign Technologies, Inc.GEI2026-07-28
00190776407292MillenniumAvalign Technologies, Inc.GEI2026-07-28
00198506092770ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092886ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28