# K970338: Tweezer-Type Epilator

- Pathway: 510(k) (Traditional)
- Applicant: Igia Direct, Inc.
- Decided: Jul 1, 1997 after 153 days
- Product code: KCX (Epilator, High Frequency, Tweezer-Type)
- Device class: 1
- Regulation: 21 CFR 878.5360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The sole indication for use of this Class [II Tweezer-Type Epilator medical device is for the removal of undesired body hairs using the techniques described in the Owner’s Instruction Brochure:

Source page: https://510kreport.com/device/K970338
Methodology: https://510kreport.com/methodology