510(k) Report

510(k) · Cleared

Cleared

Light Relief, Model LR150, LR200

K070974510(k) SpecialCleared May 24, 200748-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

Light Relief, LLC · ILY Lamp, Infrared, Therapeutic Heating

Cleared on May 24, 2007 as substantially equivalent to K993686 (Bioscan, Inc., 2000) after a 48-day review. Its family tree reaches back 1 generation to 2000. 7 later devices descend from it.

Decided
May 24, 2007
Review
48 days
Class
Class II
Product code
ILY
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K993686 (2000). 7 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2009: 1 descendant cleared2012: 2 descendants cleared2017: 1 descendant cleared2015: 2 descendants cleared2016: 1 descendant clearedK993686 · Light Patch · Bioscan, Inc. · 2000200020052010201520202025
Descendants, by generation 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K993686 · Light Patch · Bioscan, Inc. · 20000
  1. Root · 1 generation backK993686 Light PatchBioscan, Inc. · 2000
  2. This deviceK070974 Light Relief, Model LR150, LR200Light Relief, LLC · 2007
  3. Descendant · cites it directly · 6 of its ownK090008 Tanda Restore, Model PtscsPharos Life Corporation · 2009
  4. Descendant · 2 generations on · 3 of its ownK120582 HeatluxHome Skinovations, Ltd. · 2012
  5. Descendant · 3 generations on · 1 of its ownK150175 HeatLux Pro IHome Skinovations, Ltd. · 2015
  6. Descendant · 2 generations on · 1 of its ownK112494 Varaya AR , Varaya SportVaraya Photoceuticals, LLC · 2012
  7. Descendant · 2 generations on · 0 of its ownK162763 Vevazz LED Heat LampVevazz, LLC · 2017

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2009: 12012: 22015: 22016: 12017: 1
2009high 2 (2012) · low 0 (2010)2026

Most influential descendants

Showing 5 of 7 · See all
  • K090008Tanda Restore, Model PtscsPharos Life Corporation · 2009 · cites it directly6descendants
  • K120582HeatluxHome Skinovations, Ltd. · 2012 · 2 generations on3descendants
  • K150175HeatLux Pro IHome Skinovations, Ltd. · 2015 · 3 generations on1descendant
  • K112494Varaya AR , Varaya SportVaraya Photoceuticals, LLC · 2012 · 2 generations on1descendant
  • K162763Vevazz LED Heat LampVevazz, LLC · 2017 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K993686Light PatchBioscan, Inc.2000—
0 (this device)K070974Light Relief, Model LR150, LR200Light Relief, LLC2007—
+1K090008Tanda Restore, Model PtscsPharos Life Corporation2009—
+2K120582HeatluxHome Skinovations, Ltd.2012—
+3K150175HeatLux Pro IHome Skinovations, Ltd.2015—
+2K112494Varaya AR , Varaya SportVaraya Photoceuticals, LLC2012—
+2K162763Vevazz LED Heat LampVevazz, LLC2017—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201220
201520
201610
201710
FIG. 1 — Lineage of K070974, 2000–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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 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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K993686Light Patch
Summary page 1
…, Therapeutic Heating (21 CFR 890.5500) Product Code: ILY 3. Predicate Device Light Relief (K993686), originally named Light Patch Purchased from Bioscan, Inc. by Light Relict, LLC 4. Intended Use The Light…
Bioscan, Inc.2000—

What descends from it? (7)

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

NumberDeviceApplicantDecidedDescendants
K090008Tanda Restore, Model PtscsPharos Life Corporation20096

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?

  • Its one ancestor has no recall.
  • Of its descendants, K090008 (Pharos Life Corporation, 2009) has gone furthest, with 6 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. 2007, this device’s year, is highlighted.

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—

What is it indicated for?

This infrared heat lamp is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating and/or maintaining tissue temperature.

* Use wherever heat application is prescribed for personal comfort and the temporary relief of minor muscular pain, joint pain and stiffness.

* Provides temporary relief of minor aches and pains in muscles and joints.

* Aids in the relaxation of muscles.

* Helps provide a temporary improved range and freedom of motion due to muscle relaxation and temporary minor pain relief.

* Provides a temporary increase in local blood circulation.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K070974: Light Relief, Model LR150, LR200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070974

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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