# FDA Record

FDA Record: [Click here](https://www.accessdata.fda.gov/cdrh_docs/pdf16/K163137.pdf)

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 & Drug Administration (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 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