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 a medical device manufactured by Dermal Photonics Corporation. It received FDA 510(k) clearance on 2017-07-12 under approval 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. It is manufactured by Dermal Photonics Corporation. The 510(k) number is K163137.
When was NIRA Beauty Skin Laser approved by the FDA?
NIRA Beauty Skin Laser received FDA 510(k) clearance on 2017-07-12, under approval number K163137.
What company makes NIRA Beauty Skin Laser?
NIRA Beauty Skin Laser is manufactured by Dermal Photonics Corporation.
What is the FDA product code for NIRA Beauty Skin Laser?
The FDA product code for NIRA Beauty Skin Laser is OHS.
Related Devices (Code: OHS)
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.