510(k) · Cleared
ClearedMicro-current facial cold and hot service (model: TPML-100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Li-Tek Electronics Technology C0., Ltd. · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on May 25, 2022 as substantially equivalent to K180900 (Uvbiotek, LLC, 2018) and 2 other predicates after a 245-day review. Its family tree reaches back 13 generations to 1995. 4 later devices descend from it.
- Decided
- May 25, 2022
- Review
- 245 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 13 generations to K943450 (1995). 112 ancestors in all, the oldest K800617 (1980). 4 later devices descend from it, 1 citing it directly.
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations between
- 3 generations backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- 2 generations backK153081 Clear Bi-LightMichael Todd, LP · 2016
- 1 generation backK180900 LED Light Therapy DeviceUvbiotek, LLC · 2018
- This deviceK213039 Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd. · 2022
- Descendant · cites it directly · 3 of its ownK243430 Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B…Shenzhen Aozemei Technology Co., Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK252146 Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909…Shenzhen Siken 3D Technology Development Co., Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK261370 LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK260767 Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial…Kam Yuen Plastic Products, Ltd. · 2026
Show all 13 generations
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 7 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 6 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 5 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 4 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 3 generations backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- 2 generations backK153081 Clear Bi-LightMichael Todd, LP · 2016
- 1 generation backK180900 LED Light Therapy DeviceUvbiotek, LLC · 2018
- This deviceK213039 Micro-current facial cold and hot service (model: TPML-100)Li-Tek Electronics Technology C0., Ltd. · 2022
Most influential descendants
Showing 4 of 4 · See all- K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)Shenzhen Aozemei Technology Co., Ltd. · 2024 · cites it directly3descendants
- K252146Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Shenzhen Siken 3D Technology Development Co., Ltd. · 2025 · 2 generations on1descendant
- K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026 · 3 generations on0descendants
- K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty…Kam Yuen Plastic Products, Ltd. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −12 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −7 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −6 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −5 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −4 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −3 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| −2 | K153081 | Clear Bi-Light | Michael Todd, LP | 2016 | — |
| −1 | K180900 | LED Light Therapy Device | Uvbiotek, LLC | 2018 | — |
| 0 (this device) | K213039 | Micro-current facial cold and hot service (model: TPML-100) | Li-Tek Electronics Technology C0., Ltd. | 2022 | — |
| +1 | K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | Shenzhen Aozemei Technology Co., Ltd. | 2024 | — |
| +2 | K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003… | Shenzhen Siken 3D Technology Development Co., Ltd. | 2025 | — |
| +3 | K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | Guangdong Newdermo Biotech Co., Ltd. | 2026 | — |
| +2 | K260767 | Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS… | Kam Yuen Plastic Products, Ltd. | 2026 | — |
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 | 2 | 0 |
| 2002 | 3 | 0 |
| 2003 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | K180900 | LED Light Therapy DeviceSummary page 5…Regulation Number: 21 CFR 878.4810 / 882.5890 Regulation Class: 2 3. Predicate Device Information Primary Predicate Device I 510(k) number: K180900 Sponsor: UVBIOTEK, LLC Classification: Over-The-Counter Powered Light Based Laser For Acne Trade… | 2018 |
| * | K201906 | Trinity ELE Plus and Trinity ELE Plus ProSummary page 5… Product Code: OLP Regulation Number: 21 CFR 878.4810 Regulation Class: 2 Secondary Predicate Device II 510(k) number: K201906 Sponsor: LG Electronics, Inc. Classification: Transcutaneous electrical nerve stimulator for pain relief… | 2021 |
| * | K162652 | Smart Photon Micro-current Device, Model: EP-300Summary page 6…ld and hot service, Model: TPML-100 File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary Predicate Device III 510(k) number: K162652 Sponsor: Li-tek Electronic Technology Corporation. Classification: Transcutaneous electrical nerve stimulator f… | 2017 |
| † | K191951 | Avazzia OTC TENS for aesthetics, model BEST-AV1™: EZZI-LIFT™ Device | 2021 |
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 |
|---|---|---|---|
| K243430 | Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) | 2024 | 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 27 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 112 ancestors have a recall of any class.
- Of its descendants, K243430 (Shenzhen Aozemei Technology Co., Ltd., 2024) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K180900.
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. 2022, 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?
Micro-current vibration facial cold and hot service is an over the counter device that is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation for over the counter aesthetic use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K213039: Micro-current facial cold and hot service (model: TPML-100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K213039
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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