FDA.reportPublic FDA data

Mini Speed HP

Primary DI
17290110121690
Brand
Mini Speed HP
Company
ALMA LASERS LTD.
Model
1
Catalog number
AAUL25101702
Published
2019-03-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep Heat
ISAMassager, Therapeutic, Electric
NUVMassager, Vacuum, Light Induced Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMIUltrasonic Diathermy For Use In Applying Therapeutic Deep HeatPhysical Medicine2
ISAMassager, Therapeutic, ElectricPhysical Medicine1
NUVMassager, Vacuum, Light Induced HeatingGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160075000Accent XLAlma Lasers, Inc.2016-08-17IMI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290110121690PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729011012169017290110121690

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic body contouring systemAn assembly of devices intended for the transdermal application of ultrasonic energy to rupture targeted fat cells in areas where they tend to enlarge (e.g., hips, thighs, abdomen, buttocks), to reshape those areas for cosmetic purposes. The assembly typically consists of a mains electricity (AC-powered) ultrasonic energy generator with user controls/interface and an ultrasonic transducer used to transmit the energy to a target area to emulsify fat cells; it may include a video imaging system that takes into account real-time body movement to precisely position the transducer during treatment. The use of this system may serve as a noninvasive outpatient procedure alternative to liposuction.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532283264
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290110123772Handpiece LP Nd:Yag 1064 Cooled for Harmony XL Pro (color cooled gray)1AAHP080315012026-03-02
07290110123741Alma Pixel 30W 120V 50/60Hz Black (Inc)1AACO17062501BA00012025-08-11
07290110123680Pixel CO2 30W 120V 50/60Hz Black (Inc)1AACO17062501BA00012025-07-08
17290110121829Soprano Titanium System 230V1AASP05091845BSR00012022-11-06
17290110122093Hybrid System 30W 120V 50/60 HZ1AACO15061980BDAZ00042021-07-11
17290110122109Hybrid System 70W 120V 50/60 HZ 1AACO15061980BDAZ00032021-07-11
17290110122116ProScan Applicator for Hybrid System1AACO051119602021-07-11
17290110122123Pixel CO2 7x7 & 9x9 Applicator for Hybrid System1AACO280319272021-07-11
17290110122130HyLight 50 VSS Applicator for US Hybrid System1AACO090321802021-07-11
17290110122147HyLight 200 VSS Applicator for US Hybrid System1AACO100321802021-07-11
17290110120785FemiLift Handpiece1AACO171113612016-09-24
17290110120952CO2 New Scanner system 100-120V 30W1AACO010212032016-09-24
17290110120976CO2 New Scanner system 100-120V 70W1AACO010212072016-09-24
17290110121621Trio Diode Laser Module1AASP02031601 2018-09-16
07290110123376ALMA HARMONY CONSOLE1AAHG25102201BR00012023-12-20
07290110123888CO2 LiteScan Applicator FOR INC1AACO030925012025-09-21
07290110122317Accent Prime System 120V For Inc.1AAAP07042201BA00012022-11-22
07290110122324Accent Prime UltraSpeed Applicator for Inc.1AAAP070422112022-11-22
07290110122331Accent Prime MiniSpeed Applicator for Inc.1AAAP070422132022-11-22
07290110122348Accent Prime Ultra Applicator for Inc.1AAAP070422152022-11-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850071298017Smart-RSTHyperion Medical Technologies, Inc.ISA2026-06-02
16973368290059MedisanaZhangzhou Easepal Medical Science And Technology Co., Ltd.ISA2026-04-30
07630039101855MASTERPULS®Storz Medical AGISA2026-04-15
08800016213034PLASONICHironic Co., ltd.IMI2026-03-18
00045915831424Human TouchHuman Touch, LLCISA2026-01-12
00045915831431Human TouchHuman Touch, LLCISA2026-01-12
00045915831448Human TouchHuman Touch, LLCISA2026-01-12
00045915831455Human TouchHuman Touch, LLCISA2026-01-12
00045915831462Human TouchHuman Touch, LLCISA2026-01-12
00045915831479Human TouchHuman Touch, LLCISA2026-01-12
00045915831486Human TouchHuman Touch, LLCISA2026-01-12
00045915831493Human TouchHuman Touch, LLCISA2026-01-12
08034108512679Plus HandpieceDEKA M.E.L.A. SRLISA2025-10-22
00197344153605MEDLINEMEDLINE INDUSTRIES, INC.ISA2025-10-17
00810113682778ManaMed Transducer Holder PatchManamed, Inc.IMI2025-09-11
08800205600003NeuclareDeepsonbio Co., LtdISA2025-08-08
08809643652087CERAGEM Master V9CERAGEM Co., Ltd.ISA2025-07-15
00074108453488CONAIRCONAIR CORPORATIONISA2024-10-07
18057592610246icoone Laser HealthcareI-TECH INDUSTRIES SRLNUV2023-11-30
18057592610277Icoone Laser MedI-TECH INDUSTRIES SRLNUV2023-11-30
18057592610307Icoone LaserI-TECH INDUSTRIES SRLNUV2023-11-30
18057592610369Icoone Laser BodyI-TECH INDUSTRIES SRLNUV2023-11-30
00810140060129RENPHO Cordless MassagerJoicom CorporationISA2023-08-07
00810140060136RENPHO Cordless MassagerJoicom CorporationISA2023-08-07
00810140060143RENPHO Cordless MassagerJoicom CorporationISA2023-08-07
00810140060150RENPHO Cordless MassagerJoicom CorporationISA2023-08-07
00810140060167RENPHO Massage GunJoicom CorporationISA2023-08-07
00810140060174RENPHO Massage GunJoicom CorporationISA2023-08-07
00810140060181RENPHO Massage GunJoicom CorporationISA2023-08-07
00810140060198RENPHO Massage GunJoicom CorporationISA2023-08-07