FDA.reportPublic FDA data

RF Pixel HP for Accent Elite System (110V)

Primary DI
17290110121775
Brand
RF Pixel HP for Accent Elite System (110V)
Company
ALMA LASERS LTD.
Model
01
Catalog number
AASP12091710
Published
2019-12-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories
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
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2
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
17290110121775PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729011012177517290110121775

GMDN Terms#

Term, Definition table
TermDefinition
Radio-frequency skin 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
532283264
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

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07290110123680Pixel CO2 30W 120V 50/60Hz Black (Inc)1AACO17062501BA00012025-07-08
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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

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