FDA.reportPublic FDA data

NIRA Bundle +

Primary DI
00850020752492
Brand
NIRA Bundle +
Company
Nira Innovations Incorporated
Model
179-000
Device description
The NIRA Laser Bundle is a set of hand-held reusable OTC non-fractional diode laser devices employing 1450 nm wavelength. The NIRA Lasesr consists of a 2 hand pieces, wall charger and 1.5 foot USB cable. The hand pieces fits in the hand and the laser light comes out of the tip. There is a single USB C connector interface that provides battery charging. The NIRA Lasers is used for treatment of periorbital wrinkles.
Published
2025-11-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

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
K222685000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163137000NIRA Beauty Skin LaserDermal Photonics Corporation2017-07-12OHS
K222685000NIRA Model 2Dermal Photonics Corp2023-02-08OHS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850020752492PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850020752492008500207524928500207524920850020752492

GMDN Terms#

Term, Definition table
TermDefinition
Dermatological laser beam guiding handpieceA hand-held component of a dermatological laser system designed to conduct a therapeutic laser (e.g., solid state laser) from the laser generator to the treatment site 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 is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Handling Environment Humidity30 Percent (%) Relative Humidity75 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius35 Degrees Celsius
Storage Environment Atmospheric Pressure50 KiloPascal106 KiloPascal
Storage Environment Humidity10 Degrees Celsius100 Degrees Celsius
Storage Environment Temperature-20 Degrees Celsius35 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
8776076472info@niraskin.com

Regulatory Flags#

DUNS number
079208137
Device count
1
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
00850020752454NIRA Pro+174-0002024-12-26
00850020752119NIRA PRO151-0002023-07-14
00850020752126NIRA Precision Laser117-0002023-04-13
00860296000142NIRA Laser104-0002019-04-25

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