FDA.reportPublic FDA data

Accent Elite II Pixel RF HP 110V (Alma Inc)

Primary DI
17290110120082
Brand
Accent Elite II Pixel RF HP 110V (Alma Inc)
Company
ALMA LASERS LTD.
Model
1
Catalog number
AASR07031307
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NUVMassager, Vacuum, Light Induced Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUVMassager, Vacuum, Light Induced HeatingGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101147000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101147000MODIFIED ALMA LASERS FAMILY OF ACCENT RADIOFREQUENCY (RF) SYSTEMAlma Lasers, Inc.2011-01-21NUV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290110120082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729011012008217290110120082

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasonic hyperthermia systemAn assembly of devices designed to produce and control the delivery of high heat (i.e., temperatures greater than 43? Celsius) to the body using ultrasonic energy for the intracorporeal or extracorporeal treatment of malignant or benign tumours, or other disease conditions. It is typically computer-controlled and is capable of producing whole-body or localized heating within tissues or organs. Energy delivered to the patient is from either an externally-mounted transducer or a transducer-containing catheter or probe used topically or inserted endoscopically or surgically. Unlike an ultrasound diathermy system, an ultrasound hyperthermia system is not used in physiotherapy applications.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532283264
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
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
07290019863359ApexRF ApplicatorINMODE M.D LTDNUV2025-06-04
07290016746433ST Single Use TipVIORA LTDNUV2025-06-03
08053782383283T-SHAPE 2B&M SRL MARKETING NEL BENESSERENUV2025-04-11
07290019863342APEX RF SystemINMODE M.D LTDNUV2025-01-09
07290016633573Define SystemINMODE M.D LTDNUV2025-01-07
07290016633726Envision SystemINMODE M.D LTDNUV2024-03-24
07290019863311InMode OPINMODE M.D LTDNUV2024-03-24
07290019863014CelluTite SystemINMODE M.D LTDNUV2024-03-19
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
00817495022727Vcontour applicatorCandela CorporationNUV2023-10-20
00817495024462SA Med. Repl. Cover 25x30mm, 4Hr, Velashape IIICandela CorporationNUV2023-10-20
00817495024578SA Repl. Flat Lrg. Cvr. 25x50mm (4 Hr) 5-Pk, Velashape IIICandela CorporationNUV2023-10-20
07290110122317Accent Prime System 120V For Inc.ALMA LASERS LTD.NUV2022-11-22
07290110122324Accent Prime UltraSpeed Applicator for Inc.ALMA LASERS LTD.NUV2022-11-22
07290110122331Accent Prime MiniSpeed Applicator for Inc.ALMA LASERS LTD.NUV2022-11-22
07290110122348Accent Prime Ultra Applicator for Inc.ALMA LASERS LTD.NUV2022-11-22
07290016633702EmPowerRF platformINMODE M.D LTDNUV2022-10-25
07290016633658FormaIINMODE M.D LTDNUV2022-01-05
17290110122154Opus Colibri 0.7mm Single-use Tip Set (X6)ALMA LASERS LTD.NUV2021-11-14
17290110122161Opus Colibri 1mm Single-use Tip Set (X6)ALMA LASERS LTD.NUV2021-11-14
17290110122178Opus Colibri 0.7mm Single-use Tip (X1)ALMA LASERS LTD.NUV2021-11-14
17290110122185Opus Colibri 1mm Single-use Tip (X1)ALMA LASERS LTD.NUV2021-11-14
17290110122192Glide Disposable Tip (x1)ALMA LASERS LTD.NUV2021-11-14
17290110122208Glide Disposable Tip Set (X12)ALMA LASERS LTD.NUV2021-11-14
17290110122086Opus Plasma ApplicatorALMA LASERS LTD.NUV2021-01-25
17290110121782Opus System 110V ALMA LASERS LTD.NUV2020-02-20
17290110121805Opus Plasma HP/ApplicatorALMA LASERS LTD.NUV2020-02-17