FDA Record

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The NIRA Precision Laser is thoroughly tested and clinically proven to be safe and effective.  Specific regulatory tests and certifications are outlined below.

USA Food Can Drug Administation (FDA)
510k Clearance Number: K163137
Trade/Device Name: Nira Beauty Skin Laser
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: OHS
Clearance Date: April 27, 2017

Efficacy: Periorbital treatment met its predefined clinical and statistical endpoint with a median reduction of 1 unit in the FWS. An improvement of at least one score was seen in 69% of subjects on overall facial wrinkles assessment. 68% of users who achieved wrinkle reduction of 1 full scale unit maintained some wrinkle improvement for at least 3 months after users stopped using NIRA.

Safety: No unanticipated or severe adverse events were reported.

Furthermore, the NIRA laser complies with the following regulations and tests.

• ETSI EN 300 440-2 v1.4.1 (2010-08): Electromagnetic compatibility and Radio spectrum Matters (ERM); Short range devices; Radio equipment to be used in the 1 GHz to 40 GHz frequency range; Part 2: Harmonized EN covering essential requirements of article 3.2 of the R&TTE Directive
• ETSI EN 301 489-1 v1.9.2 (2011-09) Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements
• ETSI EN 301 489-3 v1.6.1 (2002-08) Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and Dermal Photonics NIRA Traditional 510(k) Premarket Notification 2-4 services; Part 3: Specific conditions for Short-Range Devices (SRD) operating on frequencies between 9 kHz and 246 GHz
• IEC 60601-1-2:2007 (Third Edition) Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
• AAMI ANSI ES 60601-1:2005(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 Medical electrical equipment—Part 1: General requirements for basic safety and essential performance
• IEC 60601-1-11: 2010 Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
• IEC 60355-1: 2010 Household and similar electrical appliances - Safety - Part 1: General requirements
• IEC 60355-2-23:2008 Household and similar electrical appliances - Safety - Part 2-23: Particular requirements for appliances for skin or hair care
• IEC 60825-1: 2007 Safety of laser products - Part 1: Equipment classification and requirements
• ASTM D4169-14 Standard Practice for Performance Testing of Shipping Containers and Systems
• IEC 62366 (First Edition) + A1:2014 Medical devices -- Part 1: Application of usability engineering to medical devices
• IEC 60601-1-6: 2010 (Third Edition) +A1;2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
• AAMI ANSI HE75: 2009/(R) 2013 Human factors engineering – Design of medical devices