510(k) · Cleared

Cleared

SmoothCool HR System

K223685510(k) SpecialCleared Jan 4, 202326-day reviewClass II21 CFR 878.4810

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

Jeisys Medical, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jan 4, 2023 as substantially equivalent to K213484 (Jeisys Medical, Inc., 2022) after a 26-day review. Its family tree reaches back 2 generations to 2008.

Decided: Jan 4, 2023
Review: 26 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K082911 (2008). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK082911 Smoothcool HR SystemJeisys Medical, Inc. · 2008
1 generation backK213484 SmoothCool HR SystemJeisys Medical, Inc. · 2022
This deviceK223685 SmoothCool HR SystemJeisys Medical, Inc. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K082911	Smoothcool HR System	Jeisys Medical, Inc.	2008	—
−1	K213484	SmoothCool HR System	Jeisys Medical, Inc.	2022	—
0 (this device)	K223685	SmoothCool HR System	Jeisys Medical, Inc.	2023	—

FIG. 1 — Lineage of K223685, 2008–2023Source: FDA 510(k) summaries, read by 510(k) Report · 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 GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

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
*	K213484	SmoothCool HR System Summary page 4 …: GEX - Regulation Number : 21 CFR 878.4810 - Review Panel : General Hospital 4. Predicate Device: - SmoothCool HR System (K213484) by Jeisys Medical Inc. 5 Device Description: The SmoothCool HR System is an Intense Pulsed Light (IPL) system used ha…	Jeisys Medical, Inc.	2022	—

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.

What does this lineage say?

The line of descent spans 15 years and passes through 1 company; a new generation was cleared every 13.3 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

The SmoothCool HR System is indicated for hair removal (permanent hair reduction).

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K223685 · printed Nov 4, 2026

Cite this page

510(k) Report. “K223685: SmoothCool HR System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223685

Report an extraction error

Are you the manufacturer?

Record history

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