# K122966: XP200

- Pathway: 510(k) (Traditional)
- Applicant: Btl Industries, Ltd.
- Decided: Apr 8, 2013 after 195 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: 18 generations back to K943450 (1995). 97 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 99 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092191: Exilis, Model 5000, Btl Industries, Ltd. (2009) Summary page 1.
- K102698: Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve Glidesafe, Ellman Int'L, Inc. (2011) Summary page 2.
- K082834: Ellman International Non-Ablative Technique for Surgitron  Iec, Ellman Int'L, Inc. (2009) Summary page 2.

## Most influential descendants
- K143109: XP300 (2015), 0 descendants of its own

## Indications for use
The XP200 device is indicated for the primary treatment of dermatologic procedures for non-invasive treatment of periorbital wrinkles and rhytids.

Source page: https://510kreport.com/device/K122966
Methodology: https://510kreport.com/methodology