Bilisoft 2.0

FDA UDI

Class II (US FDA UDI)

by Lumitex, Inc.

Identity

Trade Name: Bilisoft 2.0 FDA UDI
Generic Name: Blanket/pad infant phototherapy unit FDA UDI
Device Name: The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in a hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia. FDA UDI
Model / Reference: 009766 FDA UDI
Description: The BiliSoft 2.0 Phototherapy System provides light therapy for the treatment of indirect hyperbilirubinemia, commonly known as neonatal jaundice, during the newborn period in a hospital or home setting. The BiliSoft 2.0 Phototherapy System emits a narrow band of blue light considered to be the most effective in the treatment of hyperbilirubinemia. FDA UDI

Identifiers

Primary DI / UDI-DI: 00812432020460 FDA UDI
510(k) Number: K053568 FDA UDI
FDA Product Code: LBI FDA UDI
GMDN Term: Blanket/pad infant phototherapy unit FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.5700 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Blanket/pad infant phototherapy unit

Bilisoft 2.0 by Lumitex, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Blanket/pad infant phototherapy unit.

Olympic Bili-Bassinet — Natus Medical Incorporated · Class II
GelMat — NEOLIGHT LLC · Class II
CloudCover Plus — NEOLIGHT LLC · Class II
BILI-THERAPY Pad Type — Atom Medical Corp · Class II
neoBLUE — Natus Medical Incorporated · Class II
neoBLUE — Natus Medical Incorporated · Class II
neoBLUE — Natus Medical Incorporated · Class II
Pad Cover(L) For BILI-THERAPY Pad Type(50 pcs/box) — Atom Medical Corp · Class II

Cleared under the same submission

K053568 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Lumitex, Inc.

Sources (1)

FDA UDI 87dfcfaf-e860-489c-8fcb-d6e919343522 34 fields · synced Jun 6, 2026