FDA.reportPublic FDA data

Aveli

Primary DI
00850036790013
Brand
Aveli
Company
Revelle Aesthetics, Inc.
Model
AVE002
Published
2024-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
FTDLamp, Surgical
GDIDissector, Surgical, General & Plastic Surgery
OUPPowered Surgical Instrument For Improvement In The Appearance Of Cellulite

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FTDLamp, SurgicalGeneral, Plastic Surgery2
GDIDissector, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1
OUPPowered Surgical Instrument For Improvement In The Appearance Of CelluliteGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212399000
K221336000
K232153000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212399000AveliNc8, Inc.2021-10-22OUP
K221336000AvéliRevelle Aesthetics, Inc.2022-08-05OUP
K232153000AvéliRevelle Aesthetics, Inc.2023-08-18OUP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850036790013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850036790013008500367900138500367900130850036790013

GMDN Terms#

Term, Definition table
TermDefinition
Cellulite fibrous tether manual cutterA hand-held manual surgical instrument intended to be used for the subdermal localization and mechanical transection of cellulite-tethering septal fibrous tissue, as a skin-contouring treatment to minimize the manifestation of cellulite. It consists of a handle with mechanical controls and a distal blade/hook designed to be inserted through a puncture in the skin surface, whereby it is manoeuvred to subcutaneously engage and cut (release) the septal fibrous tissue. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity15 Degrees Celsius90 Degrees Celsius
Storage Environment Temperature0 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
117419977
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
00850036790020AliteAVE0032025-09-01
00850036790006AveliAVE0012022-02-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10194665008857A-decA-DEC, INC.FTD2026-05-07
07898789390039GRAIVIER MID-FACE DISSECTOR LEFTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390046GRAIVIER MID-FACE DISSECTOR RIGHTTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
07898789390060FRONTO MARTINS 2 ENDOFOREHEAD DISSECTORTOYO COMERCIO IMPORTACAO E EXPORTACAO DE INSTRUMENTOS CIRURGICOS LTDAGDI2026-03-25
10850009233032BihlerMedBihlerMed, L.L.C.FTD2026-01-12
00196449034512Anatomic Access LLIFTyber Medical, LLCGDI2025-10-22
B773KLEDL0KLYOKLYO MEDICAL SYSTEMS INC.FTD2024-02-22
B773KLEDS0KLYOKLYO MEDICAL SYSTEMS INC.FTD2024-02-22
10840199523402DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533302DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533319 DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533326DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533357DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533364DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533371DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533449DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533456DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533463DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533470DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533487DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533524DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533531DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533548DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533555DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533562DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199533579DissectorKOROS U.S.A., INC.GDI2024-02-06
10840199507853DissectorKOROS U.S.A., INC.GDI2024-02-05
10840199507860DissectorKOROS U.S.A., INC.GDI2024-02-05
10840199507884DissectorKOROS U.S.A., INC.GDI2024-02-05
10840199507891DissectorKOROS U.S.A., INC.GDI2024-02-05