510(k) Report

510(k) · Cleared

Cleared

TDP, Lark Brand and Mit Lamp

K875052510(k) TraditionalCleared Jun 23, 1988197-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

I.E.C. Co. · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Jun 23, 1988 after a 197-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 315 later devices descend from it.

Decided
Jun 23, 1988
Review
197 days
Class
Class II
Product code
ILY
Recalls
None
Predicates
0

315 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2015: 14 descendants cleared2003: 4 descendants cleared2004: 4 descendants cleared2005: 6 descendants cleared2006: 5 descendants cleared2008: 10 descendants cleared2007: 2 descendants cleared2011: 5 descendants cleared2022: 31 descendants cleared2009: 3 descendants cleared2014: 7 descendants cleared2010: 4 descendants cleared2012: 4 descendants cleared2013: 5 descendants cleared2018: 16 descendants cleared2020: 25 descendants cleared2019: 15 descendants cleared2021: 22 descendants cleared2016: 15 descendants cleared2024: 29 descendants cleared2026: 19 descendants cleared2017: 12 descendants cleared2025: 36 descendants cleared2023: 21 descendants cleared1990200020102020
  1. This deviceK875052 TDP, Lark Brand and Mit LampI.E.C. Co. · 1988
  2. 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
  3. Descendant · 2 generations on · 308 of its ownK024179 Palomar LightcubePalomar Medical Products, Inc. · 2003
  4. Descendant · 3 generations on · 294 of its ownK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
  5. Descendant · 4 generations on · 241 of its ownK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
  6. Descendant · 4 generations on · 239 of its ownK050370 Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005

Showing 5 of 315 descendants. See all descendants

Descendants cleared per year

2002: 12003: 42004: 42005: 62006: 52007: 22008: 102009: 32010: 42011: 52012: 42013: 52014: 72015: 142016: 152017: 122018: 162019: 152020: 252021: 222022: 312023: 212024: 292025: 362026: 19
2002high 36 (2025) · low 1 (2002)2026

Most influential descendants

Showing 5 of 315 · 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 · 2 generations on308descendants
  • K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004 · 3 generations on294descendants
  • K042165Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · 4 generations on241descendants
  • K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005 · 4 generations on239descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K875052TDP, Lark Brand and Mit LampI.E.C. Co.1988—
+1K020851TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B…C&H International2002—
+2K024179Palomar LightcubePalomar Medical Products, Inc.2003—
+3K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc.2004—
+4K042165Cutera Tabletop Aesthetic ProductCutera, Inc.20041
+4K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc.2005—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200340
200440
200560
200650
200720
2008100
200930
201040
201150
201240
201350
201470
2015140
2016150
2017120
2018160
2019150
2020250
2021220
2022310
2023210
2024290
2025360
2026190
FIG. 1 — Lineage of K875052, 1988–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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? (315)

See all 315

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K020851TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B…C&H International2002314

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

2007: 102008: 162009: 132010: 82011: 92012: 112013: 92014: 112015: 112016: 82017: 52020: 12022: 22023: 12024: 12025: 12026 (partial year): 1
2007high 16 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILY

116in 2017

2007: 128 days median2008: 165 days median2009: 189 days median2010: 185 days median2011: 198 days median2012: 130 days median2013: 211 days median2014: 153 days median2015: 146 days median2016: 214 days median2017: 116 days median
2007high 214 (2016) · low 116 (2017)2026

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

Recalls per year · ILY

1in 2025

2010: 12012: 32022: 42023: 12025: 12026 (partial year): 1
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

2007: 242008: 202009: 92010: 72011: 102012: 72013: 82015: 22016: 22017: 122018: 12019: 72020: 52021: 52022: 22023: 152024: 192025: 17
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200710128024
200816165020
20091318909
2010818517
20119198010
20121113037
2013921108
20141115300
20151114602
2016821402
20175116012
20180—01
20190—07
20201—05
20210—05
20222—42
20231—115
20241—019
20251—117
20261—1—
Cite this page

510(k) Report. “K875052: TDP, Lark Brand and Mit Lamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K875052

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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