510(k) · Cleared

Cleared

Lumilisse IPL Hair Remover

K172791510(k) TraditionalCleared Jan 18, 2018125-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

Conair Corporation · OHT Light Based Over-The-Counter Hair Removal

Cleared on Jan 18, 2018 as substantially equivalent to K103184 (Home Skinovations, Ltd., 2010) after a 125-day review. Its family tree reaches back 12 generations to 1995. 25 later devices descend from it.

Decided: Jan 18, 2018
Review: 125 days
Class: Class II
Product code: OHT
Recalls: None
Predicates: 1

Its longest line of descent runs back 12 generations to K950019 (1995). 41 ancestors in all, the oldest K892514 (1990). 25 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 12 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
8 generations between
3 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
2 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
1 generation backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
This deviceK172791 Lumilisse IPL Hair RemoverConair Corporation · 2018
Descendant · cites it directly · 22 of its ownK190820 Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd. · 2019
Descendant · 2 generations on · 15 of its ownK213558 IPL Hair Removal DeviceUlike Co., Ltd. · 2022
Descendant · 2 generations on · 14 of its ownK212907 Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd. · 2021
Descendant · 3 generations on · 12 of its ownK221214 Hand-held IPL device (IPL Home Use Hair Removal Device)…Shenzhen Ionka Medical Technology Co., Ltd. · 2022
Descendant · 4 generations on · 11 of its ownK230739 Hand-held IPL device (IPL Home Use Hair Removal Device), Model…Shenzhen Ionka Medical Technology Co., Ltd. · 2023

Show all 12 generations

Root · 12 generations backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
11 generations backK963947 Epilaser Normal Mode Ruby LaserSpectrum Medical Technologies, Inc. · 1997
10 generations backK973324 Starlight Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1997
9 generations backK982940 Lightsheer Pulsed Diode Array Laser SystemStar Medical Technologies, Inc. · 1999
8 generations backK011747 Palomar LC 100 Diode LaserPalomar Medical Technologies, Inc. · 2001
7 generations backK032846 Spectra Pulsed Diode Laser, Model DR-1Spectragenics, Inc. · 2003
6 generations backK052848 Spectra Hair Removal LaserSpectragenics, Inc. · 2005
5 generations backK060839 Abc Hair Removal SystemPalomar Medical Technologies, Inc. · 2006
4 generations backK072906 SILK'NHome Skinovations, Ltd. · 2008
3 generations backK082298 Flash N' GOHome Skinovations, Ltd. · 2008
2 generations backK090820 Tria Hair Removal Laser SystemSpectragenics, Inc. · 2009
1 generation backK103184 Silk'n Flash N GOHome Skinovations, Ltd. · 2010
This deviceK172791 Lumilisse IPL Hair RemoverConair Corporation · 2018

Showing 5 of 25 descendants. See all descendants

Descendants cleared per year

2018high 5 (2025) · low 0 (2020)2026

Most influential descendants

Showing 5 of 25 · See all

K190820Aimanfun Lumea ComfortKam Yuen Plastic Products, Ltd. · 2019 · cites it directly22descendants
K213558IPL Hair Removal DeviceUlike Co., Ltd. · 2022 · 2 generations on15descendants
K212907Aimanfun Lumea Comfort, A-2789/A-3588Kam Yuen Plastic Products, Ltd. · 2021 · 2 generations on14descendants
K221214Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd. · 2022 · 3 generations on12descendants
K230739Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608, FZ-608G, FZ-100…Shenzhen Ionka Medical Technology Co., Ltd. · 2023 · 4 generations on11descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−12	K950019	Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100	Thermolase Corp.	1995	—
−11	K963947	Epilaser Normal Mode Ruby Laser	Spectrum Medical Technologies, Inc.	1997	—
−10	K973324	Starlight Pulsed Diode Array Laser System	Star Medical Technologies, Inc.	1997	—
−9	K982940	Lightsheer Pulsed Diode Array Laser System	Star Medical Technologies, Inc.	1999	—
−8	K011747	Palomar LC 100 Diode Laser	Palomar Medical Technologies, Inc.	2001	—
−7	K032846	Spectra Pulsed Diode Laser, Model DR-1	Spectragenics, Inc.	2003	—
−6	K052848	Spectra Hair Removal Laser	Spectragenics, Inc.	2005	—
−5	K060839	Abc Hair Removal System	Palomar Medical Technologies, Inc.	2006	—
−4	K072906	SILK'N	Home Skinovations, Ltd.	2008	—
−3	K082298	Flash N' GO	Home Skinovations, Ltd.	2008	—
−2	K090820	Tria Hair Removal Laser System	Spectragenics, Inc.	2009	—
−1	K103184	Silk'n Flash N GO	Home Skinovations, Ltd.	2010	—
0 (this device)	K172791	Lumilisse IPL Hair Remover	Conair Corporation	2018	—
+1	K190820	Aimanfun Lumea Comfort	Kam Yuen Plastic Products, Ltd.	2019	—
+2	K213558	IPL Hair Removal Device	Ulike Co., Ltd.	2022	—
+2	K212907	Aimanfun Lumea Comfort, A-2789/A-3588	Kam Yuen Plastic Products, Ltd.	2021	—
+3	K221214	Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G…	Shenzhen Ionka Medical Technology Co., Ltd.	2022	—
+4	K230739	Hand-held IPL device (IPL Home Use Hair Removal Device), Model: FZ-608…	Shenzhen Ionka Medical Technology Co., Ltd.	2023	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1992	1	0
1993	1	0
1996	2	0
1997	4	0
1998	4	0
1999	2	0
2000	4	0
2001	4	0
2002	2	0
2003	2	0
2005	1	0
2008	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2018	1	0
2019	2	0
2021	4	0
2022	4	0
2023	2	0
2024	3	0
2025	5	0
2026	4	0

FIG. 1 — Lineage of K172791, 1995–2026Source: 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 OHT? 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 OHT device

#1 K221002 IPL Hair Removal Device, Model (s): UI04A…score 36.1 · 20 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
*	K103184	Silk'n Flash N GO Summary page 4 …Manufacturer Brand Name 510(k) Number Primary Home Skinovations Ltd. Silk’n Flash N Go K103184 Reference Syneron Beauty Ltd. mē K131649 Reference CyDen Ltd.…	Home Skinovations, Ltd.	2010	—
†	K131649	ME	Syneron Beauty, Ltd.	2013	—
†	K160968	iPulse SmoothSkin Gold Hair Removal Device	Cyden Limited	2016	—

Also cleared against K103184: 6 other devices →

What descends from it? (25)

See all 25

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K190820	Aimanfun Lumea Comfort	Kam Yuen Plastic Products, Ltd.	2019	22
K211368	IPL Hair Remover, Model: G993, G996, G998 and G885	Shenzhen Mywin Technology Co., Ltd.	2021	1
K181734	Beurer IPL 8500 device/ IPL VelvetSkin Pro	Home Well Trading, Ltd.	2018	1
K212099	Red Wave Hair Removal	Shenzhen Accompany Technology Co., Ltd.	2021	0

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 23 years and passes through 7 companies; a new generation was cleared every 1.3 years on median.
1 of the 41 ancestors has a recall of any class.
Of its descendants, K190820 (Kam Yuen Plastic Products, Ltd., 2019) has gone furthest, with 22 descendants of its own.
6 other devices also cite its predicate K103184.

How does its category compare?

All OHT devices

OHT Light Based Over-The-Counter Hair Removal: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.

FDA decisions per year · OHT

25in 2025

2007high 32 (2023) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OHT

87in 2025

2007high 166 (2014) · low 62 (2024)2026

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

Recalls per year · OHT

No recall names OHT since 2007.

Adverse event reports per year · OHT

6in 2025

2007high 6 (2023) · low 0 (2007)2025

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

View these four charts as a table

Year	Decisions	Median 510(k) review, days	MAUDE reports
2007	0	—	0
2008	0	—	0
2009	0	—	0
2010	1	—	0
2011	0	—	0
2012	1	—	0
2013	2	—	0
2014	4	166	0
2015	2	—	1
2016	3	81	2
2017	6	87	0
2018	8	89	0
2019	7	64	2
2020	1	—	3
2021	12	89	1
2022	25	70	2
2023	32	83	6
2024	26	62	0
2025	25	87	6
2026	11	84	—

What is it indicated for?

The Lumilisse IPL (Intense Pulsed Light) Hair Remover is an over-the-counter device intended for the removal of unwanted 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/K172791 · printed Nov 6, 2026

Cite this page

510(k) Report. “K172791: Lumilisse IPL Hair Remover.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172791

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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