510(k) Report

510(k) · Cleared

Cleared

LightStim Professional LED Bed

K153399510(k) TraditionalCleared Jul 5, 2016224-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

Led Intellectual Properties, LLC · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Jul 5, 2016 as substantially equivalent to K083580 (Led Intellectual Properties, LLC, 2009) and 2 other predicates after a 224-day review. Its family tree reaches back 14 generations to 1995. 3 later devices descend from it.

Decided
Jul 5, 2016
Review
224 days
Class
Class II
Product code
ILY
Recalls
None
Predicates
3

Its longest line of descent runs back 14 generations to K943450 (1995). 103 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2012: 1 other ancestor2006: 1 other ancestor2005: 4 other ancestors2003: 1 other ancestor2002: 3 other ancestors2010: 1 other ancestor2008: 1 other ancestor1998: 10 other ancestors2004: 1 other ancestor2000: 6 other ancestors2001: 1 other ancestor1999: 4 other ancestors1996: 12 other ancestors1995: 9 other ancestors1997: 13 other ancestors1994: 8 other ancestors1993: 3 other ancestors1991: 3 other ancestors1990: 1 other ancestor1980: 1 other ancestor1992: 3 other ancestors1985: 1 other ancestor2025: 2 descendants cleared2026: 1 descendant clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) ×2: 2 generations cleared close together, K964849 (1997), K971532 (1997) K974521 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1998K982816 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1999K022266 · Aurora SR · Syneron Medical, Ltd. · 2002K030426 · Omnilux Red · Photo Therapeutics Limited · 2003K050216 · Omnilux Revive and Omnilux Plus · Photo Therapeutics Limited · 2005K072459 · Omnilux New-U · Photo Therapeutics, Inc. · 2008K092800 · Anti-Wrinkle (Aging) Light, Model Aal · Led Intellectual Properties, LLC · 2010×2: 2 generations cleared close together, K150098 (2015), K151333 (2015) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 5 other ancestors3 generations back: 6 other ancestors4 generations back: 2 other ancestors5 generations back: 3 other ancestors6 generations back: 13 other ancestors7 generations back: 25 other ancestors8 generations back: 18 other ancestors9 generations back: 14 other ancestors10 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 1 descendant K151333 · LightStim for Pain LED Belt · Led Intellectual Properties, LLC · 2015K150098 · LightStim Professional 2-Panel Light · Led Intellectual Properties, LLC · 2015K092800 · Anti-Wrinkle (Aging) Light, Model Aal · Led Intellectual Properties, LLC · 2010K072459 · Omnilux New-U · Photo Therapeutics, Inc. · 2008K050216 · Omnilux Revive and Omnilux Plus · Photo Therapeutics Limited · 2005K030426 · Omnilux Red · Photo Therapeutics Limited · 2003K022266 · Aurora SR · Syneron Medical, Ltd. · 2002K982816 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1999K974521 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1998K971532 · Arthrocare Electrosurgery System · Arthrocare Corp. · 1997K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−10−50
  1. Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 10 generations between
  3. 3 generations backK092800 Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC · 2010
  4. 2 generations backK150098 LightStim Professional 2-Panel LightLed Intellectual Properties, LLC · 2015
  5. 1 generation backK151333 LightStim for Pain LED BeltLed Intellectual Properties, LLC · 2015
  6. This deviceK153399 LightStim Professional LED BedLed Intellectual Properties, LLC · 2016
  7. Descendant · cites it directly · 1 of its ownK241947 EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
  8. Descendant · 2 generations on · 0 of its ownK260688 Sculpt LED Belt…Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
  9. Descendant · cites it directly · 0 of its ownK252786 Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited. · 2025
Show all 14 generations
  1. Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 10 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
  6. 9 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
  7. 8 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
  8. 7 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
  9. 6 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
  10. 5 generations backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
  11. 4 generations backK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008
  12. 3 generations backK092800 Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC · 2010
  13. 2 generations backK150098 LightStim Professional 2-Panel LightLed Intellectual Properties, LLC · 2015
  14. 1 generation backK151333 LightStim for Pain LED BeltLed Intellectual Properties, LLC · 2015
  15. This deviceK153399 LightStim Professional LED BedLed Intellectual Properties, LLC · 2016

Most influential descendants

Showing 3 of 3 · See all
  • K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · cites it directly1descendant
  • K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · 2 generations on0descendants
  • K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited. · 2025 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−14K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−13K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−12K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−11K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−10K971532Arthrocare Electrosurgery SystemArthrocare Corp.1997—
−9K974521Vnus Closure SystemVnus Medical Technologies, Inc.1998—
−8K982816Vnus Closure SystemVnus Medical Technologies, Inc.1999—
−7K022266Aurora SRSyneron Medical, Ltd.2002—
−6K030426Omnilux RedPhoto Therapeutics Limited2003—
−5K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005—
−4K072459Omnilux New-UPhoto Therapeutics, Inc.2008—
−3K092800Anti-Wrinkle (Aging) Light, Model AalLed Intellectual Properties, LLC2010—
−2K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC2015—
−1K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC2015—
0 (this device)K153399LightStim Professional LED BedLed Intellectual Properties, LLC2016—
+1K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.2025—
+2K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd.2026—
+1K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
199010
199130
199230
199330
199480
199590
1996120
1997130
1998100
199940
200060
200110
200230
200310
200410
200540
200610
200810
200910
201010
201210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
202520
202610
FIG. 1 — Lineage of K153399, 1995–2026Source: 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
Get a 510(k) Report

What was it cleared against? (3)

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
*K083580Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301
Summary page 4
…Professional LED Bed Classification Code and name: ILY – Infrared Lamp, Therapeutic Heating 3. Predicate Devices LED Intellectual Properties LLC: Pain Therapy Light (K083580, LightStim Professional 2- Panel Light (K150098), LightStim LED Belt (K151333) 4. Device Description The LightStim Professional…
Led Intellectual Properties, LLC2009—
*K150098LightStim Professional 2-Panel Light
Summary page 4
…ame: ILY – Infrared Lamp, Therapeutic Heating 3. Predicate Devices LED Intellectual Properties LLC: Pain Therapy Light (K083580, LightStim Professional 2- Panel Light (K150098), LightStim LED Belt (K151333) 4. Device Description The LightStim Professional LED Bed is a device that is similar in design t…
Led Intellectual Properties, LLC2015—
*K151333LightStim for Pain LED Belt
Summary page 4
…apeutic Heating 3. Predicate Devices LED Intellectual Properties LLC: Pain Therapy Light (K083580, LightStim Professional 2- Panel Light (K150098), LightStim LED Belt (K151333) 4. Device Description The LightStim Professional LED Bed is a device that is similar in design to the bottom half of a tanning…
Led Intellectual Properties, LLC2015—

Also cleared against K083580: 3 other devices →

What descends from it? (3)

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

NumberDeviceApplicantDecidedDescendants
K241947EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd.20251
K252786Led Light Phototherapy Bed (Pro 450/ GY-680A)Shenzhen Suyzeko Limited.20250

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 21 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
  • 3 of the 103 ancestors have a recall of any class.
  • Of its descendants, K241947 (Shenzhen Kaiyan Medical Equipment Co., Ltd., 2025) has gone furthest, with 1 descendant of its own.
  • 3 other devices also cite its predicate K083580.

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. 2016, 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?

The LightStim Professional LED Bed is an over-the-counter device intended to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K153399: LightStim Professional LED Bed.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153399

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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