510(k) · Cleared
ClearedPulsaderm ACE-All Blue
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nutra Luxe MD, LLC · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Dec 15, 2016 as substantially equivalent to K132838 (Nutra Luxe MD, LLC, 2014) and 1 other predicate after a 113-day review. Its family tree reaches back 4 generations to 1998.
- Decided
- Dec 15, 2016
- Review
- 113 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K982082 (1998). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK982082 Handisol Wound HealingNational Biological Corp. · 1998
- 3 generations backK043377 ZENOTyrell, Inc. · 2005
- 2 generations backK080591 Tanda Skincare System, Model: PtscsPharos Life Corporation · 2008
- 1 generation backK124042 Tanda Mini Skincare SystemSyneron Beauty · 2013
- This deviceK162371 Pulsaderm ACE-All BlueNutra Luxe MD, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K982082 | Handisol Wound Healing | National Biological Corp. | 1998 | — |
| −3 | K043377 | ZENO | Tyrell, Inc. | 2005 | — |
| −2 | K080591 | Tanda Skincare System, Model: Ptscs | Pharos Life Corporation | 2008 | — |
| −1 | K124042 | Tanda Mini Skincare System | Syneron Beauty | 2013 | — |
| 0 (this device) | K162371 | Pulsaderm ACE-All Blue | Nutra Luxe MD, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2014 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K132838 | Nutra Light BlueSummary page 5…ild to moderate acne on the face. 6. Technological Characteristics and substantial equivalence: Pulsaderm ACE-AII Blue is substantially equivalent to Nutra Light Blue (k132838) and Tanda Mini Skin Care System (k124042). Pulsaderm ACE-All Blue is a smaller version of the predicate device Nutra Light Blue… | 2014 |
| * | K124042 | Tanda Mini Skincare SystemSummary page 4…k) Number Manufacturer 1XWUD/LJKW%OXH . 1XWUD/X[H0'//& Tanda Mini Skincare System K124042 Syneron Beauty Inc. 30 4. Device Descriptio… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 5 companies; a new generation was cleared every 4.4 years on median.
- None of the 12 ancestors has a recall.
- 1 other device also cites its predicate K132838.
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. 2016, 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?
Pulsaderm ACE-All Blue is indicated to treat mild to moderate acne on the face.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162371 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162371: Pulsaderm ACE-All Blue.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162371
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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