FDA.reportPublic FDA data

NIRA Laser

Primary DI
00860296000142
Brand
NIRA Laser
Company
Nira Innovations Incorporated
Model
104-000
Device description
The NIRA Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single micro-USB connector interface that provides two functions: battery charging and USB communication (for charging, factory programming setup and factory diagnosis of returned devices). The NIRA Laser is used for treatment of periorbital wrinkles.
Published
2019-04-25
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163137000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163137000NIRA Beauty Skin LaserDermal Photonics Corporation2017-07-12OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860296000142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860296000142008602960001428602960001420860296000142

GMDN Terms#

Term, Definition table
TermDefinition
Laser skin surface treatment system applicatorA handpiece that is part of a skin surface treatment system that conducts one or more generated laser-based energies (e.g., Er:YAG lasers; Er:Glass lasers, long-pulsed Nd:YAG laser, and Q-switched Nd:YAG laser) used for ablative and non-ablative treatment of the skin (e.g., removal of pigment/vascular lesions, scarring, wrinkles, tattoos, hair, and skin resurfacing and rejuvenation). This device is connected to a generator and is applied by a practitioner or staff directly to the area to be treated. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature-40 Degrees Fahrenheit122 Degrees Fahrenheit
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity100 Percent (%) Relative Humidity
Storage Environment Temperature-4 Degrees Fahrenheit95 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079208137
Device count
1
Kit
true
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850020752263NIRA Bundle (Pro Gen 3, White)181-000-C012025-12-08
00850020752430NIRA Pro (Gen 3,white)180-000-C012025-12-08
00850020752447NIRA Precision Laser118-000-C012025-12-08
00850020752560NIRA Pro+ (Champagne)174-000-C022025-12-08
00850020752577NIRA Pro (Gen 3,Champagne)180-000-C022025-12-08
00850020752584NIRA Bundle (Gen 2 Pro, Champagne)179-000-C022025-12-08
00850020752591NIRA Bundle (Pro Gen 3, Champagne)181-000-C022025-12-08
00850020752492NIRA Bundle +179-0002025-11-19
00850020752454NIRA Pro+174-0002024-12-26
00850020752119NIRA PRO151-0002023-07-14
00850020752126NIRA Precision Laser117-0002023-04-13

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