Identity
- Trade Name
- BLISS SYSTEM FDA UDI
- Generic Name
- Low-intensity laser fat liquefaction system FDA UDI
- Device Name
- The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the Venus Bliss device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy combined with massage and magnetic field pulses: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite FDA UDI
- Model / Reference
- BL000001 FDA UDI
- Description
- The Venus Bliss device is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. In addition, the Venus Bliss device is intended for the treatment of the following medical conditions; using the MP2 applicator for delivery of RF energy combined with massage and magnetic field pulses: • Relief of minor muscle aches and pain, relief of muscle spasm • Temporary improvement of local blood circulation • Temporary reduction in the appearance of cellulite FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07290016541281 FDA UDI
- 510(k) Number
- K190743 FDA UDI
- FDA Product Code
- PKT FDA UDIPBX FDA UDI
- GMDN Term
- Low-intensity laser fat liquefaction system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5400 FDA UDI878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radio-frequency skin/body contouring systemLow-intensity laser fat liquefaction system
Bliss System by Venus Concept Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- UltraSlim Digital — Photonica USA LLC · Class II
- Cellulize — Photonica USA LLC · Class II
Cleared under the same submission
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 670feab4-666c-4e62-971b-51ea8e482808 34 fields · synced Jun 1, 2026