# K250734: OptiLUV Device

- Pathway: 510(k) (Traditional)
- Applicant: Pollogen, Ltd.
- Decided: Sep 10, 2025 after 183 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 317 ancestors in all.
No later device cites it as a predicate yet.
0 of 318 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181095: RF-Relief, El Global Trade, Ltd. (2018) Summary page 5.

## Indications for use
The OptiLUV device is a handheld device intended to emit energy in the RF spectrum to provide topical heating for the purpose of elevating facial tissue temperature for a temporary relief of minor pain and the temporary increase in local blood circulation.

Source page: https://510kreport.com/device/K250734
Methodology: https://510kreport.com/methodology