510(k) · Cleared
ClearedPulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pulsaderm, LLC · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Apr 14, 2017 as substantially equivalent to K140471 (La Lumiere, LLC, 2015) and 1 other predicate after a 137-day review. Its family tree reaches back 12 generations to 1995. 106 later devices descend from it.
- Decided
- Apr 14, 2017
- Review
- 137 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 12 generations to K943450 (1995). 92 ancestors in all, the oldest K800617 (1980). 106 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 2 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 1 generation backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- This deviceK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- Descendant · cites it directly · 93 of its ownK170984 LG Beauty Led MaskLg Electronics · 2017
- Descendant · 2 generations on · 71 of its ownK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- Descendant · cites it directly · 56 of its ownK171323 Biophotas CELLUMA3Biophotas, Inc. · 2017
- Descendant · 2 generations on · 48 of its ownK183671 LG Pra.L Derma Led MaskLg Electronics.Inc · 2019
- Descendant · 2 generations on · 46 of its ownK200983 Infrared light therapy led facial light therapy mask-Derma plus…Ningbo Hesi Electric Co., Ltd. · 2021
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 6 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 5 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 4 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 3 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 2 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 1 generation backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- This deviceK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
Showing 5 of 106 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 106 · See all- K170984LG Beauty Led MaskLg Electronics · 2017 · cites it directly93descendants
- K191629faceLITEIsmart Marketing Svcs, Ltd. · 2019 · 2 generations on71descendants
- K171323Biophotas CELLUMA3Biophotas, Inc. · 2017 · cites it directly56descendants
- K183671LG Pra.L Derma Led MaskLg Electronics.Inc · 2019 · 2 generations on48descendants
- K200983Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin…Ningbo Hesi Electric Co., Ltd. · 2021 · 2 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −6 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −5 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −4 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −3 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −2 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −1 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| 0 (this device) | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| +1 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| +2 | K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019 | — |
| +1 | K171323 | Biophotas CELLUMA3 | Biophotas, Inc. | 2017 | — |
| +2 | K183671 | LG Pra.L Derma Led Mask | Lg Electronics.Inc | 2019 | — |
| +2 | K200983 | Infrared light therapy led facial light therapy mask-Derma plus, Photons… | Ningbo Hesi Electric Co., Ltd. | 2021 | — |
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 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 8 | 0 |
| 2023 | 11 | 0 |
| 2024 | 11 | 0 |
| 2025 | 43 | 0 |
| 2026 | 21 | 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 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 K223544 LED light therapy mask (FM-01, FM-02, FM-03)score 48.4 · 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 |
|---|---|---|---|
| * | K140471 | Pro X Otc 5Summary page 4…3. Predicate Devices: Device Name K Number Manufacturer Pro X OTC 5 Light Therapy K140471 La Lumiere, LLC Quasar Calypso C100 Wrinkle Reduction Device, Baby Quasar… | 2015 |
| * | K130225 | Quasar C100, Baby Quasar Plus, Quasar MD Plus; Wrinkle Reduction DeviceSummary page 4…K140471 La Lumiere, LLC Quasar Calypso C100 Wrinkle Reduction Device, Baby Quasar K130225 Silver Bay, LLC Plus, Quasar MD Plus 4. Device Description: The Pulsaderm Wrinkle Mask 28 and Wri… | 2013 |
What descends from it? (106)
See all 1063 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)
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 22 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 92 ancestors have a recall of any class.
- Of its descendants, K170984 (Lg Electronics, 2017) has gone furthest, with 93 descendants of its own.
- 3 other devices also cite its predicate K140471.
How does its category compare?
All OHS devicesOHS Light Based Over The Counter Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · OHS
42in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHS
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHS
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHS
34in 2025
MAUDE reports naming product code OHS, 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 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 176 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 4 | 310 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 168 | 0 | 1 |
| 2015 | 4 | 241 | 0 | 0 |
| 2016 | 3 | 191 | 0 | 0 |
| 2017 | 8 | 133 | 0 | 1 |
| 2018 | 7 | 84 | 0 | 1 |
| 2019 | 4 | 99 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 7 | 162 | 0 | 2 |
| 2022 | 16 | 129 | 0 | 2 |
| 2023 | 12 | 101 | 0 | 4 |
| 2024 | 16 | 87 | 0 | 5 |
| 2025 | 42 | 89 | 0 | 34 |
| 2026 | 26 | 88 | 0 | — |
What is it indicated for?
The Pulsaderm Wrinkle Mask 28 and 72 are intended for the use in the treatment of facial wrinkles and for people with Fitzpatrick Skin Types I, II and/or III.
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/K163329 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163329: Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163329
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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