510(k) · Cleared
ClearedPulsaderm Acne Device
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 Oct 19, 2016 as substantially equivalent to K124042 (Syneron Beauty, 2013) and 2 other predicates after a 96-day review. Its family tree reaches back 11 generations to 1995. 4 later devices descend from it.
- Decided
- Oct 19, 2016
- Review
- 96 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K943450 (1995). 95 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 1 citing it directly.
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations between
- 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 2 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 1 generation backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- This deviceK161941 Pulsaderm Acne DeviceNutra Luxe MD, LLC · 2016
- Descendant · cites it directly · 3 of its ownK161434 Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies · 2017
- Descendant · 2 generations on · 1 of its ownK250761 KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK252272 ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK251076 Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D…Shenzhen Lifotronic Technology Co., Ltd. · 2025
Show all 11 generations
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 5 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 4 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 3 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 2 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 1 generation backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- This deviceK161941 Pulsaderm Acne DeviceNutra Luxe MD, LLC · 2016
Most influential descendants
Showing 4 of 4 · See all- K161434Photon Vibrating massage Facial Aesthetic Device (Model: UI-200)Li-Tek Electronics Technologies · 2017 · cites it directly3descendants
- K250761KALA Therapy Wand (Model: KALA-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · 2 generations on1descendant
- K252272ORA Method LED Gua Sha (GS-04)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · 3 generations on0descendants
- K251076Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E)Shenzhen Lifotronic Technology Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −10 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −5 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −4 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −3 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −2 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −1 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| 0 (this device) | K161941 | Pulsaderm Acne Device | Nutra Luxe MD, LLC | 2016 | — |
| +1 | K161434 | Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) | Li-Tek Electronics Technologies | 2017 | — |
| +2 | K250761 | KALA Therapy Wand (Model: KALA-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
| +3 | K252272 | ORA Method LED Gua Sha (GS-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
| +2 | K251076 | Diode Laser Hair Removal Machine (models: T60A, T60B, T60C, T60D, T60E) | Shenzhen Lifotronic Technology Co., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 13 | 0 |
| 1998 | 9 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2025 | 3 | 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 25.5 · 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 |
|---|---|---|---|
| * | K124042 | Tanda Mini Skincare SystemSummary page 5…to the following predicate devices; Device 510(k) Number Manufacturer Tanda Mini Skincare System K124042 Syneron Beauty Inc. illuMask Acne Light Therapy Mask K123999 La Lumiere, LLC Omnilu… | 2013 |
| * | K123999 | Illumask Acne Light Therapy MaskSummary page 5…umber Manufacturer Tanda Mini Skincare System K124042 Syneron Beauty Inc. illuMask Acne Light Therapy Mask K123999 La Lumiere, LLC Omnilux Clear-U K081307 Photo Therapeutics Inc… | 2013 |
| * | K081307 | Omnilux Clear-USummary page 5…42 Syneron Beauty Inc. illuMask Acne Light Therapy Mask K123999 La Lumiere, LLC Omnilux Clear-U K081307 Photo Therapeutics Inc 30 4. Device Desc… | 2009 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K161434 | Photon Vibrating massage Facial Aesthetic Device (Model: UI-200) | 2017 | 3 |
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 21 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 3 of the 95 ancestors have a recall of any class.
- Of its descendants, K161434 (Li-Tek Electronics Technologies, 2017) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K124042.
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 Acne Device is intended to emit energy in the red and blue region of the spectrum, specifically indicated to
treat mild to moderate acne on the face.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161941 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161941: Pulsaderm Acne Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161941
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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