FDA.reportPublic FDA data

Vivaer ARC Stylus

Primary DI
08886479300146
Brand
Vivaer ARC Stylus
Company
Aerin Medical Inc.
Model
FG257
Catalog number
CAT410
Device description
The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue. The Vivaer ARC Stylus consists of a handle, shaft and treatment tip. An array of bipolar electrodes is positioned on a non-conductive tip which is attached to a handle via a non-conductive shaft. A temperature sensor is located on the tip to monitor tissue temperature. The Stylus is intended to attach to a temperature-controlled radiofrequency generator (Aerin Console) via a flexible cable.
Published
2017-12-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K172529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172529000Vivaer ARC StylusAerin Medical, Inc.2017-12-05GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08886479300146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08886479300146088864793001468886479300146

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 inert gas-enhanced electrosurgery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature5 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8334848237customerservice@aerinmedical.com

Regulatory Flags#

DUNS number
051512253
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08886479300306RhinAer+ StylusFG2258CAT22592025-09-19
08886479300023InSeca ARC StylusFG256CAT4092017-12-19
08886479300160VivAer® StylusFG722CAT7232020-10-19
08886479300184RhinAer StylusFG815CAT8212020-02-03
08886479300269VivAer® StylusFG1787CAT17852024-01-05
08886479300030Aerin ConsoleFG226CAT3052017-12-19
08886479300238RhinAer® StylusFG1393CAT13942022-08-19
08886479300047Aerin Console SetCAT305CAT305-022017-12-19
08886479300283Aerin ConsoleFG2045CAT20462024-12-18
08886479300290Aerin Console SetFG2045CAT2046-012024-12-18
08886479300252Reach NeedleCAT1614-05CAT1614-052024-06-10
28886479300256Reach NeedleCAT1614-05CAT1614-052024-06-10
08886479300108Power Cord (OUS)MS589CAT309-012023-10-19
08886479300122Power Cord (UK)MS588CAT309-032023-10-19
08886479300207Power Cord (OUS) 15 FTMS1222CAT309-042023-10-19
08886479300221Power Cord (UK) 15 FTMS1223CAT309-062023-10-19
08886479300115Power CordCAT309-02CAT309-022017-12-19
08886479300139Foot SwitchCAT307CAT3072017-12-19
08886479300214Power Cord 15 ft (US)MS1198309-052021-07-15
28886479300157Sterile Aquasonic 100 Ultrasound Transmission GelMS303CAT447-Q062017-12-19

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Primary DI, Brand, Company table
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