510(k) · Cleared

Cleared

Sonique Hair Remover

K973174510(k) TraditionalCleared Oct 30, 199766-day reviewClass I21 CFR 878.5360

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Global TV Concepts, Ltd. · KCX Epilator, High Frequency, Tweezer-Type

Cleared on Oct 30, 1997 after a 66-day review. The FDA summary names its predicate without a number.

Decided: Oct 30, 1997
Review: 66 days
Class: Class I
Product code: KCX
Recalls: None
Predicates: 0

The FDA summary names its predicate without a number.

FIG. 1 — Lineage of K973174Source: FDA 510(k) database · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in KCX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Candidate predicates for a device like this, rankedin the report
Recall history across each candidate’s familyin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	—	IGIA Hair Removal System Named without a submission number			—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All KCX devices

KCX Epilator, High Frequency, Tweezer-Type: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KCX

FDA has decided no KCX device since 2007.

Median 510(k) review, days · KCX

Too few KCX 510(k)s in any year since 2007 to give a median.

Recalls per year · KCX

No recall names KCX since 2007.

Adverse event reports per year · KCX

1in 2014

2007high 2 (2012) · low 0 (2007)2025

MAUDE reports naming product code KCX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Median 510(k) review, days	MAUDE reports
2007	—	0
2008	—	0
2009	—	0
2010	—	0
2011	—	0
2012	—	2
2013	—	0
2014	—	1
2015	—	0
2016	—	0
2017	—	0
2018	—	0
2019	—	0
2020	—	0
2021	—	0
2022	—	0
2023	—	0
2024	—	0
2025	—	0
2026	—	—

What is it indicated for?

For the removal of hair

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K973174 · printed Nov 5, 2026

Cite this page

510(k) Report. “K973174: Sonique Hair Remover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K973174

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Page last updated Nov 3, 2026