OptiLUV Device
FDA 510(k) K250734 · Pollogen, Ltd.
510(k) numberK250734
Submission
- Device name
- OptiLUV Device
- Applicant
- Pollogen, Ltd.
Tel Aviv, IL - Received
- March 11, 2025
- Decision date
- September 10, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PBX – Massager, Vacuum, Radio Frequency Induced Heat
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Generates heat in body tissues for minor relief of minor aches and pain. Mechanical massaging to provide a temporary reduction in the appearance of cellulite.
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Questions and answers
When was OptiLUV Device cleared by the FDA?
OptiLUV Device (K250734) received a 510(k) decision of Substantially Equivalent on September 10, 2025, 183 days after the submission was received.
What is the product code of K250734?
The FDA product code is PBX – Massager, Vacuum, Radio Frequency Induced Heat, a Class II (moderate risk) device regulated under 21 CFR 878.4400.