FDA.reportPublic FDA data

AirSculpt Console

Primary DI
00850000712201
Brand
AirSculpt Console
Company
Millennium Medical Technologies, Inc.
Model
AIRS-1
Published
2025-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
QPBSystem, Suction, Lipoplasty For Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QPBSystem, Suction, Lipoplasty For RemovalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241835000AirSculpt Body Contouring System (AIRS-1-SYS)Cellmyx2024-11-27QPB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850000712201PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850000712201008500007122018500007122010850000712201

GMDN Terms#

Term, Definition table
TermDefinition
Liposuction systemAn assembly of devices designed specifically to aspirate subcutaneous fat from the body by means of suction during a liposuction/lipectomy procedure. The system consists of an electrically-powered suction pump, typically with collection containers, tubing, and microbial/hydrophobic filters, and includes patient contact devices (e.g., handpiece/tip, cannula). The pump generates negative pressure for aspiration of fat through the patient contact device, which is inserted subcutaneously into the fat layer, and into the collection containers.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
968286021
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850000712478Autoclavable Suction Jar with Hose Barb extension - 250mLC-10250H2026-01-29
00850000712485Autoclavable Suction Jar with Hose Barb extension - 500mLC-10500H2026-01-29
00850000712492Autoclavable Suction Jar with Hose Barb extension - 1000mLC-101000H2026-01-29
00850000712508Autoclavable Suction Jar with Hose Barb extension - 2000mLC-102000H2026-01-29
00850000712515Autoclavable Suction Jar with Hose Barb extension - 3000mLC-103000H2026-01-29
00850000712119Disposable Fat Extraction cannula 3.4dis X 20cmMMT-D-100-202023-08-07
00850000712140Disposable Milli SuperG cannula 3.4mm X 20cm longMMT-D-100-3008500007121402023-08-07
00850000712164Disposable SuperG mini cannula 2.5mm X 20cm long, 12 holeMMT-D-100-52023-08-07
00850000712171Disposable cannula 2.5mm dia C 20cm long, 3 slotsMMT-D-100-62023-08-07
00850000712188Disposable cannula 2.0mm X 20cm long, 6 spiral slotsMMT-D-100-72023-08-07
00850000712195Disposable cannula 14ga X 10cm cupMMT-D-100-82023-08-07
00850000712249Super G Micro cannula 2.5mm X 250mm long, 300 holesMMT-D-SGM-252502023-08-07
00850000712157MMTIntellifat2023-06-12
00850000712379AirSculpt HandpieceAS-HP-100002025-06-04
00850000712430AirSculpt Triple-Port TubingAS-80002025-06-04
00850000712331AirSculpt SystemAIRS-1-SYS2025-06-03
00850000712461AirSculpt Air Hose (IN)TD-100102025-06-03
00850000712423Acquicell ProCMXPRO-5002025-04-24
00850000712096Infiltration Large Bore TubingFAT-10002-IN2023-08-07
00850000712270Dual Spike infiltration tubing IT-100022023-08-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840329838225BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.QPB2026-06-08
00607151051006AYON™ Power Liposuction Tubing AdaptorAPYX MEDICAL CORPORATIONQPB2026-05-14
00607151057008AYON™ Power Liposuction HandpieceAPYX MEDICAL CORPORATIONQPB2026-05-14
00607151057015AYON™ Power Liposuction CableAPYX MEDICAL CORPORATIONQPB2026-05-14
08800028800031LSSA (NP-200)NewpongQPB2026-05-06
03701416200035EUROMIEuromiQPB2025-08-27
03701416203388EUROMIEuromiQPB2025-08-27
03701416203401EUROMIEuromiQPB2025-08-27
00847399017413MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017420MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017437MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017444MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017451MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017468MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017475MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017482MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017499MicroAire® Microaire Surgical Instruments LLCQPB2025-08-01
00847399017505MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399017512MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
00847399018960MicroAire®Microaire Surgical Instruments LLCQPB2025-08-01
04260170880048WAL applicatorHuman Med AGQPB2025-07-30
04260170880505WAL applicatorHuman Med AGQPB2025-07-30
04260170880826WAL CannulaHuman Med AGQPB2025-07-30
04260170880864WAL CannulaHuman Med AGQPB2025-07-30
04260170880888WAL CannulaHuman Med AGQPB2025-07-30
04260170880901WAL CannulaHuman Med AGQPB2025-07-30
04260170880925WAL CannulaHuman Med AGQPB2025-07-30
04260170880949WAL CannulaHuman Med AGQPB2025-07-30
04260170880963WAL CannulaHuman Med AGQPB2025-07-30
04260170881007Biofill CannulaHuman Med AGQPB2025-07-30