# K143109: XP300

- Pathway: 510(k) (Special)
- Applicant: BTL Industries, Inc.
- Decided: Mar 6, 2015 after 128 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- 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: 19 generations back to K943450 (1995). 98 ancestors in all.
No later device cites it as a predicate yet.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122966: XP200, Btl Industries, Ltd. (2013) Summary page 6.

## Indications for use
The XP300 device is indicated for the primary treatment of dermatological procedures for non-invasive treatment of periorbital wrinkles and rhytids.

Source page: https://510kreport.com/device/K143109
Methodology: https://510kreport.com/methodology