510(k) · Cleared
ClearedDeScribe Transparent PFD Patch
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
On Light Sciences, Inc. · PKO Transparent Patch For Use In Treatment Of Tattoos
Cleared on Apr 20, 2015 as substantially equivalent to K950019 (Thermolase Corp., 1995) and 1 other predicate after an 80-day review. Its family tree reaches back 1 generation to 1995. 3 later devices descend from it.
- Decided
- Apr 20, 2015
- Review
- 80 days
- Class
- Class II
- Product code
- PKO
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K950019 (1995). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK950019 Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase…Thermolase Corp. · 1995
- This deviceK150212 DeScribe Transparent PFD PatchOn Light Sciences, Inc. · 2015
- Descendant · cites it directly · 1 of its ownK190542 Soliton Acoustic Wave DeviceSoliton, Inc. · 2019
- Descendant · 2 generations on · 0 of its ownK200331 Rapid Acoustic Pulse DeviceSoliton, Inc. · 2020
- Descendant · cites it directly · 0 of its ownK172689 DESCRIBE PFD PatchMerz North America, Inc. · 2017
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100 | Thermolase Corp. | 1995 | — |
| 0 (this device) | K150212 | DeScribe Transparent PFD Patch | On Light Sciences, Inc. | 2015 | — |
| +1 | K190542 | Soliton Acoustic Wave Device | Soliton, Inc. | 2019 | — |
| +2 | K200331 | Rapid Acoustic Pulse Device | Soliton, Inc. | 2020 | — |
| +1 | K172689 | DESCRIBE PFD Patch | Merz North America, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 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 PKO? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K950019 | Thermolase LT-100 ND:Yag Laser Hair Removal System; Thermolase LT-100;LT-100Summary page 5…21 C.F.R. § 878.4810 PKO Product Code: GEX Classification Panel: General and Plastic Surgery Predicate Device: Thermolase Corp. Carbon black solution (K950019; K971207) Reference Devices: Creative Technologies, Meladine (K022807) Palomar Q-YAG, Carbon Solution (K023967)… | 1995 |
| * | K971207 | Softlight Q-Switched (ND:Yag) LaserSummary page 5…. § 878.4810 PKO Product Code: GEX Classification Panel: General and Plastic Surgery Predicate Device: Thermolase Corp. Carbon black solution (K950019; K971207) Reference Devices: Creative Technologies, Meladine (K022807) Palomar Q-YAG, Carbon Solution (K023967) Intended… | 1998 |
| † | K022807 | Meladine Natural Melanin Enhancer, Product Number CT81602AA | 2003 |
| † | K023967 | Palomar Q-Yag ND:Yag Laser System | 2003 |
What descends from it? (3)
2 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?
How does its category compare?
All PKO devicesPKO Transparent Patch For Use In Treatment Of Tattoos: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · PKO
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · PKO
Too few PKO 510(k)s in any year since 2007 to give a median.
Recalls per year · PKO
No recall names PKO since 2007.
Adverse event reports per year · PKO
1in 2025
MAUDE reports naming product code PKO, 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 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Describe® Transparent PFD Patch is indicated for use as an accessory to laser tattoo removal procedures using a 755nm Q-Switched Alexandrite laser in Fitzpatrick Skin Type I-III patients.
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/K150212 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150212: DeScribe Transparent PFD Patch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150212
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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