FDA.reportPublic FDA data

Renuvion®

Primary DI
00607151050214
Brand
Renuvion®
Company
APYX MEDICAL CORPORATION
Model
APYX-DERM-SP
Catalog number
APYX-DERM-SP
Device description
Renuvion® Spacer, Derm
Published
2022-07-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
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
K211652000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211652000Renuvion Dermal Handpiece, Renuvion Dermal SystemApyx Medical Corporation (Formerly Bovie Medical Corporation2022-05-25GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00607151050214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00607151050214006071510502146071510502140607151050214

GMDN Terms#

Term, Definition table
TermDefinition
Electrosurgical handpiece, single-useA sterile hand-held component of an electrosurgical system intended to provide an electrical connection between the system generator and a detachable electrode at its distal end, enabling the surgeon controlled manipulation of the electrode during surgery; the electrode is not included. The device is typically in the form of a pen with permanently attached cables for connection to a generator; it is not intended for use during argon-enhanced electrosurgery. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling 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
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00607151050559AYON Ultrasound Assisted Liposuction Handpiece AYON-UAL-00012025-05-29
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
07613327666878N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666885N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666892N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666908N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666915N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
07613327666922N/ASTRYKER SUSTAINABILITY SOLUTIONS, INC.GEI2026-06-25
00190776421755MillenniumAvalign Technologies, Inc.GEI2026-06-24
00813527028590E SurgicalNEW DEANTRONICS TAIWAN LTD.GEI2026-06-23
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