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)

Opera Lebody (Gold), Opera Lebody (Zafiro)

K-Number: K201107 · 2020-06-22

ApplicantGtg Wellness Co., Ltd.
Decision Date2020-06-22
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Opera Lebody (Gold), Opera Lebody (Zafiro) is the device name listed in this FDA 510(k) record. The listed applicant is Gtg Wellness Co., Ltd.. It received FDA 510(k) clearance on 2020-06-22 under 510(k) number K201107. 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 Opera Lebody (Gold), Opera Lebody (Zafiro)?

Opera Lebody (Gold), Opera Lebody (Zafiro) is a medical device that received FDA 510(k) clearance on 2020-06-22. The listed applicant is Gtg Wellness Co., Ltd.. The 510(k) number is K201107.

When did Opera Lebody (Gold), Opera Lebody (Zafiro) receive FDA 510(k) clearance?

Opera Lebody (Gold), Opera Lebody (Zafiro) received FDA 510(k) clearance on 2020-06-22, under 510(k) number K201107.

Who is the listed applicant for Opera Lebody (Gold), Opera Lebody (Zafiro)?

The FDA 510(k) record lists Gtg Wellness Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Opera Lebody (Gold), Opera Lebody (Zafiro)?

The FDA product code for Opera Lebody (Gold), Opera Lebody (Zafiro) is OHS.

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.

↑