FDA.reportPublic FDA data

Opus System 110V

Primary DI
17290110121782
Brand
Opus System 110V
Company
ALMA LASERS LTD.
Model
1
Catalog number
AASP12091701BA0001
Published
2020-02-20
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
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
17290110121782PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729011012178217290110121782

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality skin surface treatment systemA mains electricity (AC-powered) mobile (on wheels) assembly of devices that uses multiple therapeutic modalities [e.g., intense pulsed light (IPL), laser, and radio-frequency (RF) energy] in combination and/or in isolation for ablative and non-ablative treatment of the skin surface (e.g., removal of pigment/vascular lesions, scarring, acne, psoriasis, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). The system includes a lamp(s) and additional energy sources (typically a laser(s), and/or a RF generator); dedicated applicators (handpieces) intended to apply the different energies to the skin are also included.

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
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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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