510(k) · Cleared
ClearedLED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Guangdong Newdermo Biotech Co., Ltd. · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Sep 16, 2026 as substantially equivalent to K243587 (Xtreem Pulse, LLC, 2025) and 5 other predicates after a 142-day review. Its family tree reaches back 19 generations to 1995.
- Decided
- Sep 16, 2026
- Review
- 142 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 19 generations to K943450 (1995). 216 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
- 2 generations backK230124 LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V. · 2023
- 1 generation backK230042 Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023
- This deviceK261370 LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 13 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 12 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 11 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 10 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 9 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 8 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 7 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 6 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
- 5 generations backK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
- 4 generations backK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
- 3 generations backK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
- 2 generations backK230124 LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V. · 2023
- 1 generation backK230042 Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023
- This deviceK261370 LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −13 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −12 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −11 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −10 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −9 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −8 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −7 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −6 | K170984 | LG Beauty Led Mask | Lg Electronics | 2017 | — |
| −5 | K191629 | faceLITE | Ismart Marketing Svcs, Ltd. | 2019 | — |
| −4 | K213184 | MZ Skin LightMAX Supercharged LED Mask 2.0 | Mz Skin | 2021 | — |
| −3 | K214103 | Shani Darden LED light therapy mask | Harpar Grace International | 2022 | — |
| −2 | K230124 | LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) | Light Tree Ventures Europe B.V. | 2023 | — |
| −1 | K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023) | Light Tree Ventures Europe B.V. | 2023 | — |
| 0 (this device) | K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | Guangdong Newdermo Biotech Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 15 | 0 |
| 1998 | 12 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 8 | 0 |
| 2002 | 12 | 0 |
| 2003 | 10 | 0 |
| 2004 | 2 | 0 |
| 2005 | 7 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 6 | 0 |
| 2018 | 8 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 7 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 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 NFO? 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 NFO device
- #1 K233010 Beagank 4T Plusscore 28.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (7)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K243587 | PureLift GLOWSummary page 5…Predicate Device(s): 1) Predicate device1 Sponsor: Xtreem Pulse LLC Device name: PureLift GLOW 510(k) Number: K243587 Guangdong Newdermo Biotech Co.,Ltd 1 / 14 Traditional 51… | 2025 |
| * | K230042 | Q-Rejuvalight Pro Facewear (Model: P19-0023)Summary page 6…onsor: Light Tree Ventures Europe B.V. Device name: Q-Rejuvalight Pro Facewear (Model: P19-0023) 510(k) Number: K230042 Regulation Number 21 CFR 878.4810 Light Based Over The Counter Wrinkle Reduction Cla… | 2023 |
| * | K214103 | Shani Darden LED light therapy maskSummary page 6…ate device3 Sponsor: HarparGrace International Device name: Shani Darden LED light therapy mask 510(k) Number: K214103 Regulation Number 21 CFR 878.4810 Light Based Over The Counter Wrinkle Reduction Cla… | 2022 |
| * | K240360 | Wrinkle Treatment Device (JM2)Summary page 6…vice4 Sponsor: Shenzhen Qianyu Technology Co., Ltd. Device name: Wrinkle Treatment Device (JM2) 510(k) Number: K240360 Regulation Number 21 CFR 878.4810 Guangdong Newdermo Biotech Co.,Ltd… | 2024 |
| Kept off the family tree | K230293 | FDA’s K230293 is TheraFace Mask Our reading of the summary gave K230293, FDA’s number for TheraFace Mask (Therabody, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Wrinkle Treatment Device (JM2)”. Kept off the family tree. Summary page 7…vice5 Sponsor: Shenzhen Qianyu Technology Co., Ltd. Device name: Wrinkle Treatment Device (JM2) 510(k) Number: K230293 Regulation Number 21 CFR 878.4810 Light Based Over The Counter Wrinkle Reduction Cla… | 2023 |
| * | K220198 | Medi Lift PLUSSummary page 7…eral & Plastic Surgery 6) Predicate device 6 Sponsor: Ya-Man, Ltd. Device name: Medi Lift PLUS 510(k) Number: K220198 Regulation Number 21 CFR 882.5890 Classification Name Stimulator, Transcutaneous Electrical, Aesthetic… | 2023 |
| * | K252146 | Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003…Summary page 7…y Device ( SKB-1703, SKB-1803, SKB- Device name: 1909, SKB-2003, SKB-2109, SKB-2129, SKB-2208PRO, SKB-2209) 510(k) Number: K252146 Regulation Number 21 CFR 882.5890 Classification Name Stimulator, Transcutaneous Electrical, Aesthetic… | 2025 |
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 13 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 216 ancestors have a recall of any class.
How does its category compare?
All NFO devicesNFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · NFO
16in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NFO
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NFO
2in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NFO
4in 2025
MAUDE reports naming product code NFO, 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 | 1 | — | 0 | 0 |
| 2008 | 3 | 550 | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 3 | 394 | 0 | 1 |
| 2012 | 3 | 160 | 2 | 0 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 1 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 7 | 189 | 0 | 0 |
| 2018 | 5 | 177 | 0 | 0 |
| 2019 | 3 | 149 | 0 | 1 |
| 2020 | 2 | — | 0 | 6 |
| 2021 | 7 | 210 | 0 | 6 |
| 2022 | 2 | — | 0 | 5 |
| 2023 | 8 | 128 | 0 | 1 |
| 2024 | 5 | 109 | 0 | 4 |
| 2025 | 16 | 124 | 0 | 4 |
| 2026 | 8 | 153 | 0 | — |
What is it indicated for?
1.Red light + Near-Infrared light: Intended for treat full face wrinkles;
2.Red light + Amber light + Dark Red light + Deep Near-Infrared light: Intended for treat full face wrinkles;
3.Dark Red light + Deep Near-Infrared light: Intended for treat full face wrinkles;
4 Blue light: Intended for treatment of mild to moderate inflammatory acne;
5.The Pulse mode is indicated for facial stimulation.
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/K261370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K261370: LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261370
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026