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

FDA 510(k)

Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty

K-Number: K214086 · 2022-12-15

ApplicantGenoss Co., Ltd.
Decision Date2022-12-15
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty is a medical device manufactured by Genoss Co., Ltd.. It received FDA 510(k) clearance on 2022-12-15 under approval number K214086. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty?

Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty is a medical device that received FDA 510(k) clearance on 2022-12-15. It is manufactured by Genoss Co., Ltd.. The 510(k) number is K214086.

When was Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty approved by the FDA?

Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty received FDA 510(k) clearance on 2022-12-15, under approval number K214086.

What company makes Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty?

Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty is manufactured by Genoss Co., Ltd..

What is the FDA product code for Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty?

The FDA product code for Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty is ELW.

Related Clinical Trials

NCT07601841 Light Therapy to Improve Sleep in TBI: Sleep-active Biomarkers and Glymphatic Function RECRUITING NCT07599124 Effectiveness of Light Therapy Across Seasons COMPLETED NCT07424703 Effect of Bright Light Therapy on Idiopathic Scoliosis RECRUITING NCT05459922 Adjunctive Bright Light Therapy for Opioid Use Disorder COMPLETED NCT07055633 Improving Cognitive Rehabilitation Outcomes RECRUITING NCT07545798 Bright Light Therapy During Inpatient Cocaine Detoxification: a Multicenter Prospective Randomized Clinical Trial NOT_YET_RECRUITING

Other Devices by Genoss Co., Ltd.

K160079rainbow Shine K153676OSTEON III K160144rainbow LS Block K170596TN-Brush K200155Bright High Flow K200153Bright Bond Universal

View all 13 devices →

Related Devices (Code: ELW)

K152615Vonflex SVericom Co., Ltd. K161774i-SilSpident Co., Ltd. K160097Image Fast Set, Image Regular SetSybron Dental Specialties K160441Identic and KromaFaze Alginate Dental Impression MaterialsKerr Corporation K152826NoCordCentrix, Inc. K152766CharmFlexDentkist, Inc.

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.

↑