510(k) Report

510(k) · Cleared

Cleared

Rejuvalite MD

K133896510(k) TraditionalCleared Nov 13, 2014328-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

Trophy Skin, Inc. · OHS Light Based Over The Counter Wrinkle Reduction

Cleared on Nov 13, 2014 as substantially equivalent to K120775 (Led Intellectual Properties, LLC, 2012) after a 328-day review. Its family tree reaches back 2 generations to 2010. 105 later devices descend from it.

Decided
Nov 13, 2014
Review
328 days
Class
Class II
Product code
OHS
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K101190 (2010). 105 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2017: 1 descendant cleared2020: 2 descendants cleared2025: 43 descendants cleared2022: 9 descendants cleared2018: 1 descendant cleared2019: 3 descendants cleared2023: 10 descendants cleared2026: 22 descendants cleared2021: 3 descendants cleared2024: 11 descendants clearedK101190 · Lightstim Anti-Wrinkle Otc Model Aal Otc · Led Intellectual Properties, LLC · 2010K120775 · Light for Wrinkles · Led Intellectual Properties, LLC · 20122010201520202025
Descendants, by generation 1 generation forward: 6 descendants2 generations forward: 13 descendants3 generations forward: 22 descendants4 generations forward: 28 descendants5 generations forward: 24 descendants6 generations forward: 6 descendants7 generations forward: 6 descendants K120775 · Light for Wrinkles · Led Intellectual Properties, LLC · 2012K101190 · Lightstim Anti-Wrinkle Otc Model Aal Otc · Led Intellectual Properties, LLC · 20100+5
  1. Root · 2 generations backK101190 Lightstim Anti-Wrinkle Otc Model Aal OtcLed Intellectual Properties, LLC · 2010
  2. 1 generation backK120775 Light for WrinklesLed Intellectual Properties, LLC · 2012
  3. This deviceK133896 Rejuvalite MDTrophy Skin, Inc. · 2014
  4. Descendant · cites it directly · 93 of its ownK170984 LG Beauty Led MaskLg Electronics · 2017
  5. Descendant · 2 generations on · 71 of its ownK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
  6. Descendant · 2 generations on · 48 of its ownK183671 LG Pra.L Derma Led MaskLg Electronics.Inc · 2019
  7. Descendant · cites it directly · 45 of its ownK180856 Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc. · 2018
  8. Descendant · 2 generations on · 42 of its ownK190443 MMSphereGalactic Beauty, LLC · 2019

Showing 5 of 105 descendants. See all descendants

Descendants cleared per year

2017: 12018: 12019: 32020: 22021: 32022: 92023: 102024: 112025: 432026: 22
2017high 43 (2025) · low 1 (2017)2026

Most influential descendants

Showing 5 of 105 · See all
  • K170984LG Beauty Led MaskLg Electronics · 2017 · cites it directly93descendants
  • K191629faceLITEIsmart Marketing Svcs, Ltd. · 2019 · 2 generations on71descendants
  • K183671LG Pra.L Derma Led MaskLg Electronics.Inc · 2019 · 2 generations on48descendants
  • K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc. · 2018 · cites it directly45descendants
  • K190443MMSphereGalactic Beauty, LLC · 2019 · 2 generations on42descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K101190Lightstim Anti-Wrinkle Otc Model Aal OtcLed Intellectual Properties, LLC2010—
−1K120775Light for WrinklesLed Intellectual Properties, LLC2012—
0 (this device)K133896Rejuvalite MDTrophy Skin, Inc.2014—
+1K170984LG Beauty Led MaskLg Electronics2017—
+2K191629faceLITEIsmart Marketing Svcs, Ltd.2019—
+2K183671LG Pra.L Derma Led MaskLg Electronics.Inc2019—
+1K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.2018—
+2K190443MMSphereGalactic Beauty, LLC2019—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201710
201810
201930
202020
202130
202290
2023100
2024110
2025430
2026220
FIG. 1 — Lineage of K133896, 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
*K120775Light for Wrinkles
Summary page 5
…device is OTC. 5. Predicate Device (s): This device is substantially equivalent to the following predicates, which are currently in safe and effective commerce: 1. K120775 – LightStim for Wrinkles (LED Intellectual) K133896 Rejuvalite MD 510k Summary…
Led Intellectual Properties, LLC2012—

Also cleared against K120775: 10 other devices →

What descends from it? (105)

See all 105

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

NumberDeviceApplicantDecidedDescendants
K170984LG Beauty Led MaskLg Electronics201793
K180856Neutrogena Light Therapy Aging Mask+Johnson & Johnson Consumer, Inc.201845
K201107Opera Lebody (Gold), Opera Lebody (Zafiro)Gtg Wellness Co., Ltd.202013
K202028dermalux Flex MDAesthetic Technology, Ltd.20205
K243492Ulike Reglow Light Therapy Device (UM10)Shenzhen Ulike Smart Electronics Co., Ltd.20253
K213285easy ClaireY & J Bio Co., Ltd.20223

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 4 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
  • None of the 2 ancestors has a recall.
  • Of its descendants, K170984 (Lg Electronics, 2017) has gone furthest, with 93 descendants of its own.
  • 10 other devices also cite its predicate K120775.

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. 2014, 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 Rejuvalite MD is an Over the Counter device that is 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. “K133896: Rejuvalite MD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133896

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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