510(k) · Cleared
ClearedPoly Clear
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medtek Skincare, LLC · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Sep 17, 2019 as substantially equivalent to K081307 (Photo Therapeutics, Inc., 2009) and 1 other predicate after a 260-day review. Its family tree reaches back 13 generations to 1995. 22 later devices descend from it.
- Decided
- Sep 17, 2019
- Review
- 260 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 13 generations to K943450 (1995). 100 ancestors in all, the oldest K800617 (1980). 22 later devices descend from it, 2 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 deviceK183708 Poly ClearMedtek Skincare, LLC · 2019
- Descendant · cites it directly · 21 of its ownK203214 DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd. · 2021
- Descendant · 2 generations on · 18 of its ownK230720 LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V. · 2023
- Descendant · 3 generations on · 16 of its ownK240089 Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024
- Descendant · 4 generations on · 6 of its ownK242700 Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024
- Descendant · 4 generations on · 3 of its ownK242593 CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M…Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
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 deviceK183708 Poly ClearMedtek Skincare, LLC · 2019
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K203214DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd. · 2021 · cites it directly21descendants
- K230720LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V. · 2023 · 2 generations on18descendants
- K240089Face Patches (MT-12MA, MT-12MC)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2024 · 3 generations on16descendants
- K242700Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A…Shenzhen Nuon Medical Equipment Co., Ltd. · 2024 · 4 generations on6descendants
- K242593CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · 4 generations on3descendants
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) | K183708 | Poly Clear | Medtek Skincare, LLC | 2019 | — |
| +1 | K203214 | DemarkQ WOW, DemarkQ POP | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
| +2 | K230720 | LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 | Light Tree Ventures Europe B.V. | 2023 | — |
| +3 | K240089 | Face Patches (MT-12MA, MT-12MC) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2024 | — |
| +4 | K242700 | Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2024 | — |
| +4 | K242593 | CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F… | Shenzhen Kaiyan Medical Equipment 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 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 12 | 0 |
| 2026 | 5 | 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? (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 |
|---|---|---|---|
| * | K081307 | Omnilux Clear-USummary page 4…General Surgery Devices Branch One - Light Based/Laser (GSDB1) 3. Predicate Device(s): 3.1 Predicate Device for All Red, All Blue treatment heads: K081307- Omnilux Clear-U (PhotoTherapuetics, Inc) 3.2 Predicate Device for Combo red/blue head: K180900-LED Light Therapy Device, Model:… | 2009 |
| * | K180900 | LED Light Therapy DeviceSummary page 4…te Device(s): 3.1 Predicate Device for All Red, All Blue treatment heads: K081307- Omnilux Clear-U (PhotoTherapuetics, Inc) 3.2 Predicate Device for Combo red/blue head: K180900-LED Light Therapy Device, Model: KN-7000C (UV Biotek, LLC (now Medtek Skin Care)) 3.3 Reference Devices : 1.… | 2018 |
| † | K151336 | LightStim Professional 2-Panel Light | 2015 |
| † | K170187 | Photodynamic Therapy Device | 2017 |
What descends from it? (22)
See all 222 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 24 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 100 ancestors have a recall of any class.
- Of its descendants, K203214 (Shenzhen Kaiyan Medical CO, Ltd., 2021) has gone furthest, with 21 descendants of its own.
- 8 other devices also cite its predicate K081307.
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. 2019, 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?
The Poly Clear combination of Red (633nm±10nm) and Blue (417nm±10nm) is intended to emit energy in the red, blue regions of the light spectrum to treat dermatological conditions, specifically indicated to treat mild to moderate acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K183708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183708: Poly Clear.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183708
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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