510(k) Report

510(k) · Cleared

Cleared

Light for Wrinkles

K120775510(k) TraditionalCleared Jun 4, 201282-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 Intellectual Properties, LLC · OHS Light Based Over The Counter Wrinkle Reduction

Cleared on Jun 4, 2012 as substantially equivalent to K101190 (Led Intellectual Properties, LLC, 2010) after an 82-day review. Its family tree reaches back 1 generation to 2010. 150 later devices descend from it.

Decided
Jun 4, 2012
Review
82 days
Class
Class II
Product code
OHS
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K101190 (2010). 150 later devices descend from it, 11 citing it directly.

Descendants, by year cleared 2017: 5 descendants cleared2012: 1 descendant cleared2015: 5 descendants cleared2022: 17 descendants cleared2019: 4 descendants cleared2014: 2 descendants cleared2026: 26 descendants cleared2020: 2 descendants cleared2025: 46 descendants cleared2018: 5 descendants cleared2023: 13 descendants cleared2016: 1 descendant cleared2021: 9 descendants cleared2024: 14 descendants clearedK101190 · Lightstim Anti-Wrinkle Otc Model Aal Otc · Led Intellectual Properties, LLC · 20102010201520202025
Descendants, by generation 1 generation forward: 11 descendants2 generations forward: 30 descendants3 generations forward: 44 descendants4 generations forward: 35 descendants5 generations forward: 24 descendants6 generations forward: 6 descendants K101190 · Lightstim Anti-Wrinkle Otc Model Aal Otc · Led Intellectual Properties, LLC · 20100+5
  1. Root · 1 generation backK101190 Lightstim Anti-Wrinkle Otc Model Aal OtcLed Intellectual Properties, LLC · 2010
  2. This deviceK120775 Light for WrinklesLed Intellectual Properties, LLC · 2012
  3. Descendant · cites it directly · 107 of its ownK140471 Pro X Otc 5La Lumiere, LLC · 2015
  4. Descendant · 2 generations on · 106 of its ownK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
  5. Descendant · cites it directly · 105 of its ownK133896 Rejuvalite MDTrophy Skin, Inc. · 2014
  6. Descendant · 2 generations on · 93 of its ownK170984 LG Beauty Led MaskLg Electronics · 2017
  7. Descendant · 3 generations on · 71 of its ownK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019

Showing 5 of 150 descendants. See all descendants

Descendants cleared per year

2012: 12014: 22015: 52016: 12017: 52018: 52019: 42020: 22021: 92022: 172023: 132024: 142025: 462026: 26
2012high 46 (2025) · low 0 (2013)2026

Most influential descendants

Showing 5 of 150 · See all
  • K140471Pro X Otc 5La Lumiere, LLC · 2015 · cites it directly107descendants
  • K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017 · 2 generations on106descendants
  • K133896Rejuvalite MDTrophy Skin, Inc. · 2014 · cites it directly105descendants
  • K170984LG Beauty Led MaskLg Electronics · 2017 · 2 generations on93descendants
  • K191629faceLITEIsmart Marketing Svcs, Ltd. · 2019 · 3 generations on71descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K101190Lightstim Anti-Wrinkle Otc Model Aal OtcLed Intellectual Properties, LLC2010—
0 (this device)K120775Light for WrinklesLed Intellectual Properties, LLC2012—
+1K140471Pro X Otc 5La Lumiere, LLC2015—
+2K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017—
+1K133896Rejuvalite MDTrophy Skin, Inc.2014—
+2K170984LG Beauty Led MaskLg Electronics2017—
+3K191629faceLITEIsmart Marketing Svcs, Ltd.2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201420
201550
201610
201750
201850
201940
202020
202190
2022170
2023130
2024140
2025460
2026260
FIG. 1 — Lineage of K120775, 2010–2026Source: 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
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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
*K101190Lightstim Anti-Wrinkle Otc Model Aal Otc
Summary page 1
…ssification Code: OHS, Class 11 Indications: Light Based Over-The-Counter Wrinkle Reduction 3. Predicate Devices LED Intellectual Properties, LLC - Light for Wrinkles (K1 01190) 4. Device Description The LightStim for Wrinkles is a hand-held device with a power output of 65mW/cm2, consisting of light em…
Led Intellectual Properties, LLC2010—

Also cleared against K101190: 3 other devices →

What descends from it? (150)

See all 150

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

NumberDeviceApplicantDecidedDescendants
K140471Pro X Otc 5La Lumiere, LLC2015107
K133896Rejuvalite MDTrophy Skin, Inc.2014105
K171323Biophotas CELLUMA3Biophotas, Inc.201756
K120560Trinity Wrinkle RemoverCarol Cole Company201248
K141181Nuve for Wrinkles, DPL Nuve for WrinklesLed Technologies, LLC201544
K190443MMSphereGalactic Beauty, LLC201942
K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510
K210823LYMA LaserLyma Life, Ltd.20222
K261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC20260
K151336LightStim Professional 2-Panel LightLed Intellectual Properties, LLC20150

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, K140471 (La Lumiere, LLC, 2015) has gone furthest, with 107 descendants of its own.
  • 3 other devices also cite its predicate K101190.

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. 2012, 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 LightStimn for Wrinkles is an over-the-counter hanod-held device intended for the use in the treatment of full-face wrinkles

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K120775: Light for Wrinkles.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120775

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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