TWEEZER-TYPE EPILATOR

• K Number: K970338
• Device Name: TWEEZER-TYPE EPILATOR
• Manufacturer: IGIA DIRECT, INC.
• Date Cleared: 1997-07-01 ( 153 days)
• Product Code: KCX
• Regulation Number: 878.5360
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

The sole indication for use of this Class III Tweezer-Type Epilator medical device is for the removal of undesired body hairs using the techniques described in the Owner's Instruction Brochure.

Device Description

Class III Tweezer-Type Epilator

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a device called "Elysee Hair Removal System." It primarily grants marketing authorization and does not contain detailed information about acceptance criteria or specific study results to prove device performance.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device, rather than providing a performance study report.

Regulation Number and Section

§ 878.5360 Tweezer-type epilator.

(a)
Identification. The tweezer-type epilator is an electrical device intended to remove hair. The energy provided at the tip of the tweezer used to remove hair may be radio frequency, galvanic (direct current), or a combination of radio frequency and galvanic energy.(b)
Classification. Class I (general controls). The device is exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.