510(k) · Cleared
Recalled · Class II · 2017Ultra Renew Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Accord Media · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Jun 17, 2014 after a 280-day review. The FDA summary names its predicate without a number. 58 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 17, 2014
- Review
- 280 days
- Class
- Class II
- Product code
- OLP
- Recalls
- 4
- Predicates
- 0
58 later devices descend from it, 3 citing it directly.
- This deviceK132833 Ultra Renew PlusAccord Media · 2014
- Descendant · cites it directly · 55 of its ownK142246 LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC · 2015
- Descendant · 2 generations on · 50 of its ownK160691 Acne Light Therapy WandZuko, Inc. · 2016
- Descendant · 3 generations on · 39 of its ownK210948 Omnilux CLEARGlobalmed Technologies · 2021
- Descendant · 4 generations on · 35 of its ownK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
- Descendant · 5 generations on · 19 of its ownK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K142246LightStim for Acne/ LightStim for Acne MiniLed Intellectual Properties, LLC · 2015 · cites it directly55descendants
- K160691Acne Light Therapy WandZuko, Inc. · 2016 · 2 generations on50descendants
- K210948Omnilux CLEARGlobalmed Technologies · 2021 · 3 generations on39descendants
- K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021 · 4 generations on35descendants
- K214103Shani Darden LED light therapy maskHarpar Grace International · 2022 · 5 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K132833 | Ultra Renew Plus | Accord Media | 2014 | — |
| +1 | K142246 | LightStim for Acne/ LightStim for Acne Mini | Led Intellectual Properties, LLC | 2015 | — |
| +2 | K160691 | Acne Light Therapy Wand | Zuko, Inc. | 2016 | — |
| +3 | K210948 | Omnilux CLEAR | Globalmed Technologies | 2021 | — |
| +4 | K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | 2021 | — |
| +5 | K214103 | Shani Darden LED light therapy mask | Harpar Grace International | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 24 | 0 |
| 2026 | 9 | 0 |
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 OLP? 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 OLP device
- #1 K214103 Shani Darden LED light therapy maskscore 25.6 · 16 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Omnilux Clear-U Named without a submission number | |
| * | — | Silk'n FX Named without a submission number | |
| * | — | Ultrasonic Therapeutic Massager (KUP-300) Named without a submission number |
What descends from it? (58)
See all 583 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 4, 2017 | Class II | Z-0819-2018 | Device Design | Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation |
| Dec 4, 2017 | Class II | Z-0820-2018 | Device Design | Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation |
| Dec 4, 2017 | Class II | Z-0822-2018 | Device Design | Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation |
| Dec 4, 2017 | Class II | Z-0821-2018 | Device Design | Distribution of medical devices with unapproved green LED light used to treat hyperpigmentation |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K142246 (Led Intellectual Properties, LLC, 2015) has gone furthest, with 55 descendants of its own.
How does its category compare?
All OLP devicesOLP Over-The-Counter Powered Light Based Laser For Acne: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · OLP
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OLP
88in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OLP
4in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OLP
1in 2025
MAUDE reports naming product code OLP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 247 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 3 | 245 | 0 | 0 |
| 2014 | 3 | 255 | 0 | 1 |
| 2015 | 3 | 159 | 0 | 0 |
| 2016 | 6 | 99 | 0 | 1 |
| 2017 | 4 | 151 | 4 | 1 |
| 2018 | 5 | 104 | 0 | 7 |
| 2019 | 2 | — | 0 | 19 |
| 2020 | 1 | — | 0 | 8 |
| 2021 | 6 | 260 | 0 | 7 |
| 2022 | 5 | 245 | 0 | 1 |
| 2023 | 3 | 109 | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 3 | 88 | 0 | 1 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Ultra Renew Plus is an over-the-counter device intended:
- To emit energy in the red and blue region of the spectrum, specifically to treat mild to moderate acne on the face
- To emit energy in the red region of the spectrum for the treatment of periorbital wrinkles.
- As an electrically powered device intended for medical purposes to relieve minor aches and pains
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132833 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132833: Ultra Renew Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132833
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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