510(k) · Cleared

Cleared

TDP CQ-27 Heat Lamp

K003538510(k) TraditionalCleared Jun 4, 2001200-day reviewClass II21 CFR 890.5500

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

Lhasa Medical, Inc. · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Jun 4, 2001 after a 200-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 447 later devices descend from it.

Decided: Jun 4, 2001
Review: 200 days
Class: Class II
Product code: ILY
Recalls: None
Predicates: 0

447 later devices descend from it, 10 citing it directly.

This deviceK003538 TDP CQ-27 Heat LampLhasa Medical, Inc. · 2001
Descendant · cites it directly · 314 of its ownK020851 TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B…C&H International · 2002
Descendant · cites it directly · 308 of its ownK024179 Palomar LightcubePalomar Medical Products, Inc. · 2003
Descendant · 2 generations on · 294 of its ownK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
Descendant · 3 generations on · 241 of its ownK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
Descendant · 3 generations on · 239 of its ownK050370 Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005

Showing 5 of 447 descendants. See all descendants

Descendants cleared per year

2002high 51 (2025) · low 2 (2002)2026

Most influential descendants

Showing 5 of 447 · See all

K020851TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B…C&H International · 2002 · cites it directly314descendants
K024179Palomar LightcubePalomar Medical Products, Inc. · 2003 · cites it directly308descendants
K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004 · 2 generations on294descendants
K042165Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · 3 generations on241descendants
K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005 · 3 generations on239descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003538	TDP CQ-27 Heat Lamp	Lhasa Medical, Inc.	2001	—
+1	K020851	TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B…	C&H International	2002	—
+1	K024179	Palomar Lightcube	Palomar Medical Products, Inc.	2003	—
+2	K033768	Altus Medical Optional Infrared Handpiece	Altus Medical, Inc.	2004	—
+3	K042165	Cutera Tabletop Aesthetic Product	Cutera, Inc.	2004	1
+3	K050370	Palomar Luxir Handpiece	Palomar Medical Technologies, Inc.	2005	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	4	0
2004	4	0
2005	9	0
2006	8	0
2007	4	0
2008	12	0
2009	9	0
2010	8	0
2011	8	0
2012	7	0
2013	9	0
2014	11	0
2015	18	0
2016	26	0
2017	21	0
2018	19	0
2019	21	0
2020	30	0
2021	31	0
2022	38	0
2023	29	0
2024	38	0
2025	51	0
2026	30	0

FIG. 1 — Lineage of K003538, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in ILY? 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 ILY device

#1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (447)

See all 447

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

Number	Device	Applicant	Decided	Descendants
K020851	TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B…	C&H International	2002	314
K024179	Palomar Lightcube	Palomar Medical Products, Inc.	2003	308
K013197	WS-501 Heat Lamp	Lhasa Medical, Inc.	2002	151
K050397	Velasmooth, Shaper	Syneron Medical, Ltd.	2005	150
K043558	Xinfeng Heat Lamps, Models, CQ-27,CQ-36, CQ-55, CQ-55A	Chongqing Xinfeng Medical Instruments Co., Ltd.	2005	4
K081720	Precision TDP, Heat and Infrared Lamps and Marvel and Wonder Lamps	Prime Herbs Corporation	2009	1
K080465	WS Far Infrared Therapy Unit, Model # TY-101 Series	Ws Far IR Medical Technology Co., Ltd.	2008	1
K110721	Gaunying Infrared Lamp	Foshan Gaunying Electronics Co., Ltd.	2011	0
K061080	IR PRO 250	Lhasa Oms, Inc.	2006	0
K052063	Huanqiu Heating Lamp	A & A Medical Supplies, Inc.	2005	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?

Of its descendants, K020851 (C&H International, 2002) has gone furthest, with 314 descendants of its own.

How does its category compare?

All ILY devices

ILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ILY

1in 2025

2007high 16 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILY

116in 2017

2007high 214 (2016) · low 116 (2017)2026

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

Recalls per year · ILY

1in 2025

2007high 4 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ILY

17in 2025

2007high 24 (2007) · low 0 (2014)2025

MAUDE reports naming product code ILY, 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	10	128	0	24
2008	16	165	0	20
2009	13	189	0	9
2010	8	185	1	7
2011	9	198	0	10
2012	11	130	3	7
2013	9	211	0	8
2014	11	153	0	0
2015	11	146	0	2
2016	8	214	0	2
2017	5	116	0	12
2018	0	—	0	1
2019	0	—	0	7
2020	1	—	0	5
2021	0	—	0	5
2022	2	—	4	2
2023	1	—	1	15
2024	1	—	0	19
2025	1	—	1	17
2026	1	—	1	—

https://510kreport.com/device/K003538 · printed Nov 5, 2026

Cite this page

510(k) Report. “K003538: TDP CQ-27 Heat Lamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K003538

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026