FDA.reportPublic FDA data

DENSITY Tip

Primary DI
08800020108289
Brand
DENSITY Tip
Company
Jeisys Medical Inc.
Model
Classic-B Tip
Device description
DENSITY Tip_Classic-B Tip
Published
2026-03-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

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
K250065000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250065000DENSITY; DENZA; DENSITY NoirJeisys Medical Incorporated2025-07-08GEI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800020108289PackageGS16In Commercial Distribution
08800020108333PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800020108289088000201082898800020108289
08800020108333088000201083338800020108333

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin/body contouring systemAn assembly of devices that uses radio-frequency (RF) electromagnetic (EM) energy [typically in the bands below 10 megahertz (MHz)] to generate heat deep within subcutaneous tissues to temporarily minimize the manifestation of cellulite and loose or wrinkled skin through a process of skin regrowth and tightening and local fat cell alteration/destruction. It typically consists of monopolar and/or bipolar applicators attached to an energy-producing generator, typically with a cooling module. The tissues are warmed to produce the desired therapeutic effect; simultaneous cryogen cooling of the epidermis may be employed. This device is not used for the treatment of malignancies.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690275362
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800020100276INTRAcel TipINTRAcel Tip 10102026-07-16
08800020100283INTRAcel TipINTRAcel Tip 32026-07-16
08800020100306INTRAcel TipINTRAcel Tip 10122026-07-16
08800020100313INTRAcel TipINTRAcel Tip 10132026-07-16
08800020100320INTRAcel TipINTRAcel Tip 20112026-07-16
08800020100337INTRAcel TipN16 Tip2026-07-16
08800020104984DENSITY TipClassic-B Tip2026-07-16
08800020104991DENSITY TipClassic-E Tip2026-07-16
08800020105004DENSITY TipClassic-F Tip2026-07-16
08800020105059DENSITY TipHigh-B Tip2026-07-16
08800020105066DENSITY TipHigh-E Tip2026-07-16
08800020105073DENSITY TipHigh-F Tip2026-07-16
08800020106322TRI-BEAMTRI-BEAM PRO2026-07-16
08800020106827DENSITY TipALPHA TIP2026-07-16
08800020107626DENSITY HandpieceDT-HP-012026-07-16
08800020107633DENSITY HandpieceDT-HP-022026-07-16
08800020109446TRI-BEAM HandpieceZOOM Handpiece 012026-07-16
08800020109453TRI-BEAM HandpieceCollimation Handpiece 012026-07-16
08800020109460TRI-BEAM Handpiece1064 Fractional Handpiece 012026-07-16
08800020109477TRI-BEAM Handpiece532 Fractional Handpiece 012026-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776398484MillenniumAvalign Technologies, Inc.GEI2026-07-16
08800020100276INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100283INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100306INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100313INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100320INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020100337INTRAcel TipJeisys Medical Inc.GEI2026-07-16
08800020104984DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020104991DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105004DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105059DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105066DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020105073DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020106827DENSITY TipJeisys Medical Inc.GEI2026-07-16
08800020107626DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020107633DENSITY HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110565INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110572INTRAcel HandpieceJeisys Medical Inc.GEI2026-07-16
08800020110640FootswitchJeisys Medical Inc.GEI2026-07-16
B382SD08890310101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD08890320101D0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720520001Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD7720585030Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD84032220032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8406210032B0Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89029200Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89039060Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89139290Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD8917450Surgical DirectSurgical Direct, Inc.GEI2026-07-14
B382SD89179290Surgical DirectSurgical Direct, Inc.GEI2026-07-14