FDA.reportPublic FDA data

Diode 1064nm Compact For Soprano

Primary DI
17290110121409
Brand
Diode 1064nm Compact For Soprano
Company
ALMA LASERS LTD.
Model
1
Catalog number
AASP10121401
Published
2017-05-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
ILYLamp, Infrared, Therapeutic Heating

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILYLamp, Infrared, Therapeutic HeatingPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
17290110121409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1729011012140917290110121409

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
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
07290110123772Handpiece LP Nd:Yag 1064 Cooled for Harmony XL Pro (color cooled gray)1AAHP080315012026-03-02
07290110123888CO2 LiteScan Applicator FOR INC1AACO030925012025-09-21
07290110123741Alma Pixel 30W 120V 50/60Hz Black (Inc)1AACO17062501BA00012025-08-11
07290110123680Pixel CO2 30W 120V 50/60Hz Black (Inc)1AACO17062501BA00012025-07-08
07290110123567Alma TED System 120V 50/60HZ1AATE16112101BA00012024-09-15
07290110123611TED Applicator1AATE171121022024-09-15
17290110123526Diode 755nm Alex Applicator for Soprano Titanium (Black)1AASP280124012024-03-17
07290110123451ClearVas1AAQS241022092024-02-18
07290110123468ClearLift1AAQS241022082024-02-18
07290110123475Alma SupErb1AAIP241022102024-02-18
07290110123482ClearSkin1AAIP241022112024-02-18
07290110123444NIR Face (6) HP1AAIP241022072024-01-30
07290110123406Iris SR IPL HP1AAIP241022062024-01-29
07290110123413Iris VL/PL IPL HP1AAIP241022022024-01-29
07290110123420Iris SHR Pro (6.4) Cooled IPL HP1AAIP241022012024-01-29
07290110123437Iris Acne IPL HP1AAIP241022052024-01-29
07290110123369ALMA HARMONY CONSOLE WITH GREEN DIODE1AAHG25102201BR00022023-12-20
07290110123376ALMA HARMONY CONSOLE1AAHG25102201BR00012023-12-20
07290110123383Iris Dye VL IPL HP1AAIP241022042023-12-20
07290110123390VascuPen Diode laser 520nm HP1AAIP241022122023-12-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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06976812430233TheraLight 360 Full Body WellnessRhein Laser Technologies Co.,Ltd.ILY2026-03-06
06977863220149Therapy LightE.SHINE LIGHTING CO., LIMITEDILY2026-03-02
06977863220156Therapy LightE.SHINE LIGHTING CO., LIMITEDILY2026-03-02
06977863220163Therapy LightE.SHINE LIGHTING CO., LIMITEDILY2026-03-02
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06978181510301QOLIGHTWuhan Qolight Technology Co., Ltd.ILY2026-02-02
06978181510318QOLIGHTWuhan Qolight Technology Co., Ltd.ILY2026-02-02
06979812520034MarrisJjwXiamen Langxing Medical Technology Co., Ltd.ILY2026-01-26
06979322350015N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
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06979322350046N/ADongguan Redthera Technology Co., Ltd.ILY2026-01-22
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