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FDA 510(k)

Acne Light Therapy Wand

K-Number: K160691 · 2016-06-21

ApplicantZuko, Inc.
Decision Date2016-06-21
Product CodeOLP
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Acne Light Therapy Wand is a medical device manufactured by Zuko, Inc.. It received FDA 510(k) clearance on 2016-06-21 under approval number K160691. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Acne Light Therapy Wand?

Acne Light Therapy Wand is a medical device that received FDA 510(k) clearance on 2016-06-21. It is manufactured by Zuko, Inc.. The 510(k) number is K160691.

When was Acne Light Therapy Wand approved by the FDA?

Acne Light Therapy Wand received FDA 510(k) clearance on 2016-06-21, under approval number K160691.

What company makes Acne Light Therapy Wand?

Acne Light Therapy Wand is manufactured by Zuko, Inc..

What is the FDA product code for Acne Light Therapy Wand?

The FDA product code for Acne Light Therapy Wand is OLP.

Related Clinical Trials

NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05738239 Photo-biomodulation Therapy for Pain Relief After Caesarean Section COMPLETED NCT07370051 Effect of Topical Oxygen and LED Light Therapy on Nipple Crack NOT_YET_RECRUITING NCT07609888 Photodynamic Therapy as an Adjunct to Non-Surgical Periodontal Therapy in Stage II Periodontitis: A Randomized Split-Mouth Study COMPLETED NCT07600957 Polarized Light Therapy for Radiation Dermatitis in Breast Cancer RECRUITING NCT07601841 Light Therapy to Improve Sleep in TBI: Sleep-active Biomarkers and Glymphatic Function RECRUITING

Related PubMed Literature

PMID: 40417352 Regulatory aspects of optogenetic research and therapy for retinitis pigmentosa under EU law. Frontiers in medical technology (2025)

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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.

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