FDA.reportPublic FDA data

Renuvion®/J-Plasma®

Primary DI
00607151050122
Brand
Renuvion®/J-Plasma®
Company
APYX MEDICAL CORPORATION
Model
APYX-HGS
Catalog number
APYX-HGS
Device description
Renuvion®/J-Plasma® Helium Gas Regulator
Published
2020-03-23
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
K142975000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142975000Bovie Ultimate High Frequency Electrosurgical GeneratorBovie Medical Corporation2014-12-12GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00607151050122PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607151050122006071510501226071510501220607151050122

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical systemAn assembly of devices intended to generate, and apply radio-frequency (RF) alternating current to soft tissues for cutting and coagulation during an endoscopic or open surgical procedure; it is not dedicated to focal ablation of specific tissues (i.e., not a radio-frequency ablation system). The assembly includes a mains electricity-powered (AC-powered) RF generator with monitoring functions/controls, connection cables, a handpiece, and electrodes to apply the energy to the surgical site. Tissue resistance to the electrical current creates the heat as the current travels through the body between electrodes; it is not intended for argon-enhanced electrosurgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity10 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
101223287
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00607151050559AYON Ultrasound Assisted Liposuction HandpieceAYON-UAL-00012025-05-29
00607151050627AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 3 ringsAYON-UAL-3733-32026-06-26
00607151050634AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 26cm length, 3 ringsAYON-UAL-3726-32026-06-26
00607151050641AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 1 ringAYON-UAL-3733-12026-06-26
00607151051006AYON™ Power Liposuction Tubing AdaptorAYON-PL-ADPT2026-05-14
00607151057008AYON™ Power Liposuction HandpieceAYON-PL-00012026-05-14
00607151057015AYON™ Power Liposuction CableAYON-PL-00022026-05-14
00607151050504AYON ConsoleAYON-CONSOLE2025-06-03
00607151050481AYON Wireless FootswitchAYON-FSW-00012025-05-29
00607151050498AYON Base TowerAYON-TOWER2025-05-29
00607151050511AYON Base Tower AYON-TOWER2025-05-29
00607151050528AYON Infiltration Handle AYON-IF-00012025-05-29
00607151050535AYON Infiltration Handle on/offAYON-IF-00022025-05-29
00607151050566AYON Ultrasound Assisted Liposuction Cable AYON-UAL-00022025-05-29
00607151050573AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 33cm length, 5 ringsAYON-UAL-3733-52025-05-29
00607151050580AYON Ultrasound Assisted Liposuction Probe: 3.7mm diameter, 26cm length, 5 ringsAYON-UAL-3726-52025-05-29
00607151050597AYON Ultrasound Assisted Liposuction Probe: 2.9mm diameter, 26cm length, 5 ringAYON-UAL-2926-52025-05-29
00607151050603AYON Ultrasound Assisted Liposuction Probe: 2.9mm diameter, 18cm length, 5 ringsAYON-UAL-2918-52025-05-29
00607151050610AYON Ultrasound Assisted Liposuction Probe: 2.2mm diameter, 18cm length, 3 ringsAYON-UAL-2218-32025-05-29
00607151050665AYON Skin Port Small 3mmAYON-SP-SMALL2025-05-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776429140MillenniumAvalign Technologies, Inc.GEI2026-09-04
00840113233281BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233304BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233328BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233342BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233366BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233380BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233403BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233427BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233441BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233465BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233489BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233502BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113233526BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237326BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237340BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237593BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237623BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237661BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
00840113237692BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-09-04
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