510(k) · Cleared
ClearedLUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Kaiyan Medical Equipment Co., Ltd. · OLP Over-The-Counter Powered Light Based Laser For Acne
Cleared on Mar 4, 2026 as substantially equivalent to K230720 (Light Tree Ventures Europe B.V., 2023) after a 90-day review. Its family tree reaches back 16 generations to 1995.
- Decided
- Mar 4, 2026
- Review
- 90 days
- Class
- Class II
- Product code
- OLP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K943450 (1995). 105 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK183118 dpl SpotLiteLed Technologies, Inc. · 2019
- 2 generations backK203214 DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd. · 2021
- 1 generation backK230720 LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V. · 2023
- This deviceK253878 LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 10 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 9 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 8 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 7 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 6 generations backK121435 Silkn BlueHome Skinovations, Ltd. · 2013
- 5 generations backK153081 Clear Bi-LightMichael Todd, LP · 2016
- 4 generations backK180447 reVive Light Therapy LED Cleansing SystemLed Technologies, Inc. · 2018
- 3 generations backK183118 dpl SpotLiteLed Technologies, Inc. · 2019
- 2 generations backK203214 DemarkQ WOW, DemarkQ POPShenzhen Kaiyan Medical CO, Ltd. · 2021
- 1 generation backK230720 LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Light Tree Ventures Europe B.V. · 2023
- This deviceK253878 LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −10 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −9 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −8 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −7 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −6 | K121435 | Silkn Blue | Home Skinovations, Ltd. | 2013 | — |
| −5 | K153081 | Clear Bi-Light | Michael Todd, LP | 2016 | — |
| −4 | K180447 | reVive Light Therapy LED Cleansing System | Led Technologies, Inc. | 2018 | — |
| −3 | K183118 | dpl SpotLite | Led Technologies, Inc. | 2019 | — |
| −2 | K203214 | DemarkQ WOW, DemarkQ POP | Shenzhen Kaiyan Medical CO, Ltd. | 2021 | — |
| −1 | K230720 | LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 | Light Tree Ventures Europe B.V. | 2023 | — |
| 0 (this device) | K253878 | LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001) | Shenzhen Kaiyan Medical Equipment Co., 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 | 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 |
| 2018 | 1 | 0 |
| 2019 | 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 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? (1)
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 |
|---|---|---|---|
| * | K230720 | LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001Summary page 5…Acne Review Panel: General & Plastic Surgery Product Code: OLP Regulation Number:21 CFR 878.4810 Regulation Class: II 3. Predicate Device Information Predicate Device (K230720) Sponsor: Light Tree Ventures Europe B.V. Trade Name: LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001 Classifi… | 2023 |
| † | K160691 | Acne Light Therapy Wand | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 11 companies; a new generation was cleared every 1.9 years on median.
- 3 of the 105 ancestors have a recall of any class.
- 1 other device also cites its predicate K230720.
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. 2026, 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?
LUSTRE GoGlow Advanced LED Patches (Model: PR8001, PR9001) is an Over-the-Counter (OTC) device that emits energy in the blue and red spectrum for the treatment of mild to moderate inflammatory acne.
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/K253878 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253878: LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253878
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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