FDA.reportPublic FDA data

Apyx®

Primary DI
00607151050221
Brand
Apyx®
Company
APYX MEDICAL CORPORATION
Model
APYX-ONE
Catalog number
APYX-ONE
Device description
Apyx One Console
Published
2022-11-01
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
K221830000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221830000Apyx One ConsoleApyx Medical Corporation2022-10-11GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00607151050221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607151050221006071510502216071510502210607151050221

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical system generatorAn electrically-powered component of a electrosurgical system intended to generate radio-frequency (RF) electrical current for subsequent cutting and coagulation of soft tissues 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 generator). It includes controls, may include an integrated surgical plume (smoke) suction unit, and is intended to be connected via a cable to an electrosurgical handpiece and electrode (neither of these are included); it is not intended for inert gas-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
DM exempt
true
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
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
00198506092893ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092909ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092916ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092954ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092961ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092978ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092985ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506092992ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506093340ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506093449ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
00198506093456ELMED INCORPORATEDELMED INCORPORATEDGEI2026-07-28
10884450452360STAR™Merit Medical Systems, Inc.GEI2026-07-28