# K063748: Thermomed 1.8

- Pathway: 510(k) (Traditional)
- Applicant: Thermosurgery Technologies, Inc.
- Decided: Feb 1, 2007 after 44 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: 2 generations back to K894166 (1989). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021117: Tti Thermomed Model 1.8 Instrument, Thermosurgery Technologies, Inc. (2002) Summary page 1.
- K894166: Thermosurgery TM, Rdm Intl., Inc. (1989) Summary page 1.
- K970493: Hyfrecator 2000, Aspen Labs (1997) Summary page 1.
- K800617: Hyfrecator, #733, Birtcher Corp. (1980) Summary page 1.

## Indications for use
The device is intended to treat benign superficial dermatological indications that includes; warts, molluscum contagiosm, angioma, fibroma, seborrheic keratoses, acrochordon, syringoma, hydrocystoma, calvus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis. In addition, it is intended to treat basal cell carcinoma.

Source page: https://510kreport.com/device/K063748
Methodology: https://510kreport.com/methodology