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FDA 510(k)

Bilicocoon™ Phototherapy System

K-Number: K163526 · 2017-10-06

ApplicantNeomedlight
Decision Date2017-10-06
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Bilicocoon™ Phototherapy System is the device name listed in this FDA 510(k) record. The listed applicant is Neomedlight. It received FDA 510(k) clearance on 2017-10-06 under 510(k) number K163526. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Bilicocoon™ Phototherapy System?

Bilicocoon™ Phototherapy System is a medical device that received FDA 510(k) clearance on 2017-10-06. The listed applicant is Neomedlight. The 510(k) number is K163526.

When did Bilicocoon™ Phototherapy System receive FDA 510(k) clearance?

Bilicocoon™ Phototherapy System received FDA 510(k) clearance on 2017-10-06, under 510(k) number K163526.

Who is the listed applicant for Bilicocoon™ Phototherapy System?

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

What is the FDA product code for Bilicocoon™ Phototherapy System?

The FDA product code for Bilicocoon™ Phototherapy System is LBI.

Related Devices (Code: LBI)

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.

K251308SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical ProductsK243372BiliWrapGerium Medical, Ltd.K210289Infant Phototherapy EquipmentBistos Co., Ltd.K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) LimitedK190899bili-hutLittle Sparrows Technologies, Inc.K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated

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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