FDA.reportPublic FDA data

Aerin Console

Primary DI
08886479300030
Brand
Aerin Console
Company
Aerin Medical Inc.
Model
FG226
Catalog number
CAT305
Device description
The Aerin Console is an AC (alternating current) radiofrequency generator. It incorporates user interface software to control, monitor and regulate RF power delivery to soft tissues via a cable-connected electrosurgical hand piece and electrode. The Aerin Console Set consists of the following items: 1) Aerin Console unit, 2) Power Cord, 3) Foot Switch and is intended for use with one or more Aerin Styli.
Published
2017-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
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
K162810000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162810000InSeca ARC Stylus, Aerin ConsoleAerin Medical, Inc.2017-01-11GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08886479300030PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08886479300030088864793000308886479300030

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 Pressure18.7 KiloPascal101.3 KiloPascal
Storage Environment Atmospheric Pressure59.5 KiloPascal101.3 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Humidity20 Percent (%) Relative Humidity85 Percent (%) Relative Humidity
Storage Environment Temperature-20 Degrees Celsius60 Degrees Celsius
Storage Environment Temperature5 Degrees Celsius60 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8334848237customerservice@aerinmedical.com

Regulatory Flags#

DUNS number
051512253
Device count
1
Serial number
true
Manufacturing 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
08886479300146Vivaer ARC StylusFG257CAT4102017-12-19
08886479300160VivAer® StylusFG722CAT7232020-10-19
08886479300184RhinAer StylusFG815CAT8212020-02-03
08886479300269VivAer® StylusFG1787CAT17852024-01-05
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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