# K021117: Tti Thermomed Model 1.8 Instrument

- Pathway: 510(k) (Special)
- Applicant: Thermosurgery Technologies, Inc.
- Decided: May 2, 2002 after 24 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: 1 generation back to K894166 (1989). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894166: Thermosurgery TM, Rdm Intl., Inc. (1989) Summary page 1.

## Most influential descendants
- K063748: Thermomed 1.8 (2007), 0 descendants of its own

## Indications for use
The TTI ThermoMed™ Model 1.8 Instrument provides the therapeutic modality to treat the following benign diseases and conditions: Warts Molluscum Contagiosum Angioma Fibroma Seborrheic Keratoses Acrochordon Syringoma Hydrocystoma 9. Clavus 10. Actinic Keratoses 11. Keloids 12. Epidermoid Cysts 13. Cystic Acne 14. Cutaneous Leishmaniasis 15. Atypical Mycobacteria 16. Dermatophytosis

Source page: https://510kreport.com/device/K021117
Methodology: https://510kreport.com/methodology