Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NIRA Beauty Skin Laser

K-Number: K163137 · 2017-07-12

ApplicantDermal Photonics Corporation
Decision Date2017-07-12
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

NIRA Beauty Skin Laser is the device name listed in this FDA 510(k) record. The listed applicant is Dermal Photonics Corporation. It received FDA 510(k) clearance on 2017-07-12 under 510(k) number K163137. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIRA Beauty Skin Laser?

NIRA Beauty Skin Laser is a medical device that received FDA 510(k) clearance on 2017-07-12. The listed applicant is Dermal Photonics Corporation. The 510(k) number is K163137.

When did NIRA Beauty Skin Laser receive FDA 510(k) clearance?

NIRA Beauty Skin Laser received FDA 510(k) clearance on 2017-07-12, under 510(k) number K163137.

Who is the listed applicant for NIRA Beauty Skin Laser?

The FDA 510(k) record lists Dermal Photonics Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIRA Beauty Skin Laser?

The FDA product code for NIRA Beauty Skin Laser is OHS.

Other records listing Dermal Photonics Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K222685NIRA Model 2

Related Devices (Code: OHS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading LimitedK261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLCK2605985 Wavelength LED Facemask (TN2508)iSMART Developments, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑