Body Laser Applicator Bliss

FDA UDI

Class II (US FDA UDI)

by Venus Concept Inc.

Identity

Trade Name: BODY LASER APPLICATOR BLISS FDA UDI
Generic Name: Low-intensity laser fat liquefaction system FDA UDI
Model / Reference: AS160004 FDA UDI

Identifiers

Primary DI / UDI-DI: 07290016541625 FDA UDI
510(k) Number: K190743 FDA UDI
FDA Product Code: PKT FDA UDI
PBX FDA UDI
GMDN Term: Low-intensity laser fat liquefaction system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 878.5400 FDA UDI
878.4400 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

FDA UDI

Category: Low-intensity laser fat liquefaction system

Body Laser Applicator Bliss by Venus Concept Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Low-intensity laser fat liquefaction system.

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Erchonia Zerona VZ8 — Erchonia Corporation · Class II
SculpSure Applicator — Cynosure, LLC · Class II
UltraSlim Digital — Photonica USA LLC · Class II
Cellulize — Photonica USA LLC · Class II

Cleared under the same submission

K190743 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: Venus Concept Inc.

Sources (1)

FDA UDI 4198e2d0-8f91-4fc1-877f-4360ebbe2a87 33 fields · synced Jun 6, 2026