510(k) Report

510(k) · Cleared

Cleared

dpl IIa Panel

K180320510(k) TraditionalCleared Apr 3, 201857-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

Led Technologies, Inc. · OHS Light Based Over The Counter Wrinkle Reduction

Cleared on Apr 3, 2018 as substantially equivalent to K171390 (Led Technologies, Inc., 2017) and 3 other predicates after a 57-day review. Its family tree reaches back 14 generations to 1995. 14 later devices descend from it.

Decided
Apr 3, 2018
Review
57 days
Class
Class II
Product code
OHS
Recalls
None
Predicates
4

Its longest line of descent runs back 14 generations to K943450 (1995). 108 ancestors in all, the oldest K800617 (1980). 14 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2017: 1 other ancestor2013: 1 other ancestor2015: 1 other ancestor2010: 3 other ancestors2008: 1 other ancestor2006: 1 other ancestor2014: 1 other ancestor2012: 2 other ancestors2007: 2 other ancestors2005: 2 other ancestors2003: 3 other ancestors2002: 3 other ancestors1998: 9 other ancestors2001: 1 other ancestor2000: 5 other ancestors1999: 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 ancestor2019: 1 descendant cleared2021: 1 descendant cleared2023: 1 descendant cleared2022: 1 descendant cleared2025: 7 descendants cleared2026: 3 descendants 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 · 2003K081307 · Omnilux Clear-U · Photo Therapeutics, Inc. · 2009K121435 · Silkn Blue · Home Skinovations, Ltd. · 2013K131461 · Lightstim for Acne/ Lightstim for Acne Mini · Led Intellectual Properties, LLC · 2014K142246 · LightStim for Acne/ LightStim for Acne Mini · Led Intellectual Properties, LLC · 2015K160691 · Acne Light Therapy Wand · Zuko, Inc. · 201619801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 4 other ancestors3 generations back: 10 other ancestors4 generations back: 6 other ancestors5 generations back: 13 other ancestors6 generations back: 25 other ancestors7 generations back: 18 other ancestors8 generations back: 14 other ancestors9 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 8 descendants4 generations forward: 2 descendants K160691 · Acne Light Therapy Wand · Zuko, Inc. · 2016K142246 · LightStim for Acne/ LightStim for Acne Mini · Led Intellectual Properties, LLC · 2015K131461 · Lightstim for Acne/ Lightstim for Acne Mini · Led Intellectual Properties, LLC · 2014K121435 · Silkn Blue · Home Skinovations, Ltd. · 2013K081307 · Omnilux Clear-U · Photo Therapeutics, Inc. · 2009K030426 · 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 backK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
  4. 2 generations backK142246 LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC · 2015
  5. 1 generation backK160691 Acne Light Therapy WandZuko, Inc. · 2016
  6. This deviceK180320 dpl IIa PanelLed Technologies, Inc. · 2018
  7. Descendant · cites it directly · 10 of its ownK183247 dpl FacewareLed Technologies, Inc. · 2019
  8. Descendant · 2 generations on · 9 of its ownK230042 Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023
  9. Descendant · cites it directly · 3 of its ownK210968 reVive Light Therapy EssentialsLed Technologies, Inc. · 2021
  10. Descendant · 3 generations on · 2 of its ownK251588 LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908…Shenzhen Fittop Health Technology Co., Ltd. · 2025
  11. Descendant · 2 generations on · 2 of its ownK223482 reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc. · 2022
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 backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
  11. 4 generations backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
  12. 3 generations backK131461 Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC · 2014
  13. 2 generations backK142246 LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC · 2015
  14. 1 generation backK160691 Acne Light Therapy WandZuko, Inc. · 2016
  15. This deviceK180320 dpl IIa PanelLed Technologies, Inc. · 2018

Showing 5 of 14 descendants. See all descendants

Descendants cleared per year

2019: 12021: 12022: 12023: 12025: 72026: 3
2019high 7 (2025) · low 0 (2020)2026

Most influential descendants

Showing 5 of 14 · See all
  • K183247dpl FacewareLed Technologies, Inc. · 2019 · cites it directly10descendants
  • K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023 · 2 generations on9descendants
  • K210968reVive Light Therapy EssentialsLed Technologies, Inc. · 2021 · cites it directly3descendants
  • K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd. · 2025 · 3 generations on2descendants
  • K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc. · 2022 · 2 generations on2descendants
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—
−5K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009—
−4K121435Silkn BlueHome Skinovations, Ltd.2013—
−3K131461Lightstim for Acne/ Lightstim for Acne MiniLed Intellectual Properties, LLC2014—
−2K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC2015—
−1K160691Acne Light Therapy WandZuko, Inc.2016—
0 (this device)K180320dpl IIa PanelLed Technologies, Inc.2018—
+1K183247dpl FacewareLed Technologies, Inc.2019—
+2K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.2023—
+1K210968reVive Light Therapy EssentialsLed Technologies, Inc.2021—
+3K251588LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910)Shenzhen Fittop Health Technology Co., Ltd.2025—
+2K223482reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
199010
199130
199230
199330
199480
199590
1996120
1997130
199890
199940
200050
200110
200230
200330
200520
200610
200720
200810
201030
201220
201310
201410
201510
201710

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201910
202110
202210
202310
202570
202630
FIG. 1 — Lineage of K180320, 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 OHS? 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 OHS device

  1. #1 K223544 LED light therapy mask (FM-01, FM-02, FM-03)score 48.4 · 16 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? (4)

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
*K171390dpl II Panel
Summary page 5
…ice is substantially equivalent to the following predicates, which are currently in safe and effective commerce under product codes OHS/OLP: K171390 – dpl® II Panel (LED Technologies, Inc.) K124042 – Tanda Mini (Tanda) K121435 – Silkin Blue (Silkin…
Led Technologies, Inc.2017—
*K124042Tanda Mini Skincare System
Summary page 5
…ch are currently in safe and effective commerce under product codes OHS/OLP: K171390 – dpl® II Panel (LED Technologies, Inc.) K124042 – Tanda Mini (Tanda) K121435 – Silkin Blue (Silkin) K160691 – Acne Light Therapy Wand (Zuco, Inc.)…
Syneron Beauty2013—
*K121435Silkn Blue
Summary page 5
…fective commerce under product codes OHS/OLP: K171390 – dpl® II Panel (LED Technologies, Inc.) K124042 – Tanda Mini (Tanda) K121435 – Silkin Blue (Silkin) K160691 – Acne Light Therapy Wand (Zuco, Inc.) Comparison Chart Device…
Home Skinovations, Ltd.2013—
*K160691Acne Light Therapy Wand
Summary page 5
…K171390 – dpl® II Panel (LED Technologies, Inc.) K124042 – Tanda Mini (Tanda) K121435 – Silkin Blue (Silkin) K160691 – Acne Light Therapy Wand (Zuco, Inc.) Comparison Chart Device dpl® IIa Panel dpl® II Panel…
Zuko, Inc.2016—

Also cleared against K171390: 5 other devices →

What descends from it? (14)

See all 14

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

NumberDeviceApplicantDecidedDescendants
K183247dpl FacewareLed Technologies, Inc.201910
K210968reVive Light Therapy EssentialsLed Technologies, Inc.20213

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 9 companies; a new generation was cleared every 1.1 years on median.
  • 4 of the 108 ancestors have a recall of any class.
  • Of its descendants, K183247 (Led Technologies, Inc., 2019) has gone furthest, with 10 descendants of its own.
  • 5 other devices also cite its predicate K171390.

How does its category compare?

All OHS devices

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

FDA decisions per year · OHS

42in 2025

2008: 22010: 32011: 22012: 42013: 22014: 52015: 42016: 32017: 82018: 72019: 42020: 22021: 72022: 162023: 122024: 162025: 422026 (partial year): 26
2007high 42 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OHS

89in 2025

2010: 176 days median2012: 310 days median2014: 168 days median2015: 241 days median2016: 191 days median2017: 133 days median2018: 84 days median2019: 99 days median2021: 162 days median2022: 129 days median2023: 101 days median2024: 87 days median2025: 89 days median2026 (partial year): 88 days median
2007high 310 (2012) · low 84 (2018)2026

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

Recalls per year · OHS

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

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

Adverse event reports per year · OHS

34in 2025

2011: 12012: 12014: 12017: 12018: 12019: 12020: 22021: 22022: 22023: 42024: 52025: 34
2007high 34 (2025) · low 0 (2007)2025

MAUDE reports naming product code OHS, 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
20070—00
20082—10
20090—00
2010317600
20112—01
2012431001
20132—00
2014516801
2015424100
2016319100
2017813301
201878401
201949901
20202—02
2021716202
20221612902
20231210104
2024168705
20254289034
202626880—

What is it indicated for?

The dpl® Ila Panel is an Over-the Counter (OTC) device intended for use in treating wrinkles, and treatment of mild to moderate inflammatory acne.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K180320: dpl IIa Panel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180320

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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