FDA.reportPublic FDA data

SCARLET SRF

Primary DI
08809502330088
Brand
SCARLET SRF
Company
VIOL Co.,Ltd.
Model
SCARLET SRF
Published
2018-11-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K180872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180872000SCARLET SRFVIOL Co., Ltd.2018-10-11GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809502330088PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809502330088088095023300888809502330088

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
695654949
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809502330422SCARLET PROSCARLET PRO2025-07-11
08809502330439FOOT SWITCHF/S-HRF-BLUE2025-07-11
08809502330446HAND PIECEH/S_032025-07-11
08809502330286CELLINEW Foot switchCELLINEW Foot Switch2024-12-09
08809502330347CELLINEWCELLINEW2024-12-09
08809502330361CELLINEW HandpieceCELLINEW Handpiece2024-12-09
08809502330378CELLINEW TIPCF402024-12-09
08809502330385CELLINEW TIPCE252024-12-09
08809502330149XE25J25BM2022-06-29
08809502330156XA25J25BS2022-06-29
08809502330163XW18J18BS2022-06-29
08809502330170HandpieceP/B2021-01-14
08809502330187Foot switchF/S-B2021-01-14
08809502330026CELFIRMCELFIRM2018-02-23
08809502330033FOOT SWITCHF/S2018-04-02
08809502330040HAND PIECEH/S_022018-04-02
08809502330101SYLFIRM XSYLFIRM X2020-04-28
28809502330013CONSUMABLE TIPConsumable Tip2018-02-23
38809502330010CONSUMABLE TIPConsumable Tip2018-09-17

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Primary DI, Brand, Company table
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