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Claims and Justification

FDA Cleared

FDA 510(k) clearance letter K222685 for NIRA Model 2, February 8, 2023 NIRA Pro 3 · FDA 510(k) K222685 Download FDA PDF FDA 510(k) clearance letter K163137 for NIRA Beauty Skincare Laser, July 12, 2017 NIRA Precision · FDA 510(k) K163137 Download FDA PDF
  • FDA cleared for treating periorbital wrinkles (see 510(k) for more details).
  • Safe for all skin types and tones (Fitzpatrick skin types I to VI).
  • Safe for adults aged 21 and older.

Testing Approved by FDA

  • Electrical safety: AAMI ANSI ES 60601-1
  • Electromagnetic compatibility: IEC 60601-1-2
  • Safe for home use: IEC 60601-1-11
  • Laser safety: IEC 60825-1
  • Usability engineering: IEC 62366 and IEC 60601-1-6
  • Human factors engineering, design of medical devices: AAMI ANSI HE75:2009/(R)2013
  • Household appliance safety for skin care devices: IEC 60335-1 and IEC 60335-2-23
  • Shipping and packaging: ASTM D4169
  • FCC requirements
  • Software documentation reviewed by FDA
  • Self-selection study: people could correctly decide from the box label alone whether NIRA is right for them
  • Usability study: NIRA was shown to be usable by its intended users at home

Learn More About FDA Clearance

Is At Home Laser FDA Cleared? What It MeansRead article → Your Guide to FDA Cleared Beauty DevicesRead article → FDA Cleared Laser Guide for At-Home Wrinkle CareRead article →

NIRA Clinical Studies

99%said NIRA was easy to use
95%would continue daily use
93%of people improved, in image analysis
69%reduced wrinkles by at least 1 full FWS point
First page of the NIRA Full Face Wrinkle Study 2025 NIRA Full Face Wrinkle Study 2025 60 adults enrolled First page of the NIRA Eye Area Wrinkle Study 2019 NIRA Eye Area Wrinkle Study 2019 76 adults enrolled
A reviewer comparing participant photos taken under identical studio lighting Blinded Review of Study Photos

NIRA studies were conducted at New England Dermatology Associates in Beverly, Massachusetts, led by board-certified dermatologist Dr. David S. Greenstein. Participants used NIRA at home every day for 4 months, then stopped for 3 months, and three independent, blinded reviewers graded their before and after photos.

Reviewers did not know which photo was taken before and which after, and scored wrinkles on the FWS from 1 to 9, where a lower score is better.

No serious adverse events were reported in NIRA studies.

  • 92%of participants would recommend NIRA
  • 91%of participants said their skin improved
  • 81%of participants still saw improvement 2 months after they stopped using NIRA
  • 73%of participants reduced wrinkles by at least 1 full FWS point by month 7, up from 31% at month 2
  • 68%of participants still saw improvement 3 months after they stopped using NIRA
  • 64%of participants improved UV spots in VISIA skin analysis
  • 58%of participants reduced wrinkles by at least 1 full FWS point in blinded review
  • 46%of participants improved skin elasticity
  • 36%of participants reduced wrinkles by 2 full FWS points

The NIRA Full Face Wrinkle Study 2025 is registered on ClinicalTrials.gov (NCT07572331).

NIRA Presented at the World's Most Prestigious Medical Laser Conference

David Bean, NIRA founder, holding NIRA at ASLMS 2026 in Savannah
ASLMS 2026 · Savannah

The ASLMS (American Society for Laser Medicine and Surgery) Annual Conference is, in ASLMS's words, “the world's most prestigious gathering of medical laser and related technology professionals.”

NIRA's study was selected for presentation, and its abstract was published in the society's peer-reviewed journal, Lasers in Surgery and Medicine.

Excerpt of NIRA's published ASLMS 2026 abstract in Lasers in Surgery and Medicine, volume 58, issue S38, pages S50 to S51 Excerpt of the published abstract, Lasers in Surgery and Medicine, 2026, volume 58, issue S38, pages S50 to S51

Read the Full Abstract

Open the abstract > Click PDF > Purchase > Sign in to Wiley > Page S50

ASLMS members can read it free: choose “Log in with your ASLMS membership”. Prices are set by Wiley and may change.

NIRA vs LED

NIRA
First page of the NIRA Full Face Wrinkle Study 2025 First page of the NIRA Eye Area Wrinkle Study 2019
NIRA Full Face Wrinkle Study 2025NIRA Eye Area Wrinkle Study 2019
vs
Therabody LED mask
Therabody 2025 TheraFace Mask Glo study page Therabody 2023 TheraFace Mask study page
Therabody LED Mask Study 2025Therabody LED Mask Study 2023

We compared NIRA's clinical studies with published Therabody LED mask and LED light studies:

  • Up to 200x the Light PowerOn the skin, compared with LED and low-level light devices.
  • 9x More People Improved93% with NIRA vs 10% with the Therabody LED mask, in image analysis.
  • 70x Better Wrinkle Results9x more people improved, and their wrinkles improved 7.5x more than with the Therabody LED mask.
  • 5x FasterAbout 2 minutes a day vs 10 to 12 minutes for LED.
  • 7x More People Improved in Blinded Review7 in 10 with NIRA vs 1 in 10 with the Therabody LED mask.
  • No Significant Improvement with LEDIn eye wrinkles, after 3 months of daily use, in blinded dermatologist review.

How NIRA Works

Dermal temperature over time: fractional lasers spike above the pain threshold toward cellular necrosis, while NIRA holds the dermis between the heat-shock protein threshold (39C) and the pain threshold (45C). Fractional lasers spike far above the pain threshold. NIRA warms the dermis gently and holds it between 39 and 45°C.
No Downtime
No Pain or Recovery
Everyday Use
  • NIRA uses a true 1450 nm laser. Its light is absorbed by water in the dermis, the layer of skin where collagen lives and wrinkles form.
  • NIRA gently warms the dermis to about 39 to 45°C, just below the pain threshold. In laboratory research by Souil and colleagues (2001) and Capon and Mordon (2003), this kind of mild heat activated the skin's natural heat-shock response. In clinical studies by Goldberg and colleagues (2002) and Tanzi and colleagues (2003), warming the dermis with a 1450 nm laser was linked to new collagen formation.
  • Unlike fractional lasers, which heat small columns of skin and often result in redness and discomfort with recovery time, NIRA's non-fractional laser warms the whole treatment area evenly.
  • NIRA uses a gentler energy level than in-office lasers. In-office treatments deliver their energy in one session every one to three months, while NIRA delivers a gentle dose every day, so over time NIRA can deliver more total energy than a single in-office treatment. NIRA Pro 3 delivers 2.1 to 3.8 J/cm² per treatment. That adds up to about 60 to 115 J/cm² over a month of daily use, compared with about 12 to 16 J/cm² in a single in-office 1450 nm laser session.
  • A full NIRA routine takes about 2 minutes a day, and results build over time as the skin's natural collagen renewal continues.
  • NIRA is safe for all skin types and tones, because its 1450 nm light is absorbed by water in the skin, not by pigment.

Quality and Manufacturing

Made in Derry, NH, USADesigned, engineered and manufactured in the USA. Every laser is individually assembled, calibrated and tested before it ships.
ISO 13485 CertifiedOur quality system is certified by Intertek under MDSAP to ISO 13485:2016, for the United States and Canada.
Audited Every YearIndependent audits every year, with zero nonconformities since 2024.
Registered in the US and CanadaOur facility is registered with the FDA, and NIRA lasers are licensed as medical devices by Health Canada.
Class 1C Laser SafetyClass 1C under IEC 60825-1. The laser fires only when its touch sensor confirms contact with the skin.
Each Device Is TraceableEvery NIRA laser can be traced from manufacturing to delivery.
Intertek ISO 13485:2016 MDSAP certificate 0207329 Intertek · MDSAP ISO 13485:2016 Certificate 0207329 View certificate

Our quality system is audited every year to ISO 13485:2016 under the Medical Device Single Audit Program (MDSAP) by Intertek, an independent MDSAP auditing organization.