(MP)2 APPLICATOR SERVICE PACK, Bliss

FDA UDI

Class II (US FDA UDI)

by Venus Concept Inc.

Identity

Trade Name: (MP)2 APPLICATOR SERVICE PACK, Bliss FDA UDI
Generic Name: Radio-frequency skin/body contouring system FDA UDI
Model / Reference: SPK160001 FDA UDI

Identifiers

Primary DI / UDI-DI: 07290016541717 FDA UDI
510(k) Number: K190743 FDA UDI
FDA Product Code: PKT FDA UDI
PBX FDA UDI
GMDN Term: Radio-frequency skin/body contouring 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

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: Radio-frequency skin/body contouring system

(MP)2 APPLICATOR SERVICE PACK, Bliss by Venus Concept Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Universal Electrosurgical Pad (3M REF 9160) — VIVEVE, INC. · Class II
Sectum Precise (Face) Applicator — NEAUVIA NORTH AMERICA, INC · 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 5172fc69-9f2e-47ab-ac61-23b388fc171c 33 fields · synced Jun 8, 2026