510(k) · Cleared
ClearedPureLift GLOW
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xtreem Pulse, LLC · NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Cleared on Mar 6, 2025 as substantially equivalent to K221443 (Xtreem Pulse, LLC, 2022) and 2 other predicates after a 106-day review. Its family tree reaches back 17 generations to 1995. 1 later device descends from it.
- Decided
- Mar 6, 2025
- Review
- 106 days
- Class
- Class II
- Product code
- NFO
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 17 generations to K943450 (1995). 134 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK180445 reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc. · 2018
- 2 generations backK210965 reVive Light Therapy EssentialsLed Technologies, Inc. · 2021
- 1 generation backK223482 reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc. · 2022
- This deviceK243587 PureLift GLOWXtreem Pulse, LLC · 2025
- Descendant · cites it directly · 0 of its ownK261370 LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 11 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 10 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 9 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 8 generations backK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- 7 generations backK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008
- 6 generations backK110301 Silk'n FXHome Skinovations, Ltd. · 2011
- 5 generations backK152332 Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity · 2016
- 4 generations backK162489 RED Light DeviceZhongshan Bisen Plastic Electronic Products Co., Ltd. · 2017
- 3 generations backK180445 reVive Light Therapy LED Ultrasonic Wrinkle SystemLed Technologies, Inc. · 2018
- 2 generations backK210965 reVive Light Therapy EssentialsLed Technologies, Inc. · 2021
- 1 generation backK223482 reVive Light Therapy® Wrinkle and Acne LED DeviceLed Technologies, Inc. · 2022
- This deviceK243587 PureLift GLOWXtreem Pulse, LLC · 2025
Most influential descendants
Showing 1 of 1 · See all- K261370LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))Guangdong Newdermo Biotech Co., Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −11 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −10 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −9 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −8 | K050216 | Omnilux Revive and Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
| −7 | K072459 | Omnilux New-U | Photo Therapeutics, Inc. | 2008 | — |
| −6 | K110301 | Silk'n FX | Home Skinovations, Ltd. | 2011 | — |
| −5 | K152332 | Perfectio LED infrared device | Omm Imports Inc Dba Zero Gravity | 2016 | — |
| −4 | K162489 | RED Light Device | Zhongshan Bisen Plastic Electronic Products Co., Ltd. | 2017 | — |
| −3 | K180445 | reVive Light Therapy LED Ultrasonic Wrinkle System | Led Technologies, Inc. | 2018 | — |
| −2 | K210965 | reVive Light Therapy Essentials | Led Technologies, Inc. | 2021 | — |
| −1 | K223482 | reVive Light Therapy® Wrinkle and Acne LED Device | Led Technologies, Inc. | 2022 | — |
| 0 (this device) | K243587 | PureLift GLOW | Xtreem Pulse, LLC | 2025 | — |
| +1 | 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 |
| 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 | 11 | 0 |
| 1999 | 4 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 4 | 0 |
| 2005 | 4 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 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? (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 |
|---|---|---|---|
| * | K221443 | PureLift Pro PlusSummary page 5…882.5890 Product Code(s) NFO I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221443 PureLift Pro Plus NFO K223482 reVive Light Therapy® Wrinkle and Acne LED Device OHS K201782 NuFace Trinity Plus Device NFO I Dev… | 2022 |
| * | K223482 | reVive Light Therapy® Wrinkle and Acne LED DeviceSummary page 5…I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221443 PureLift Pro Plus NFO K223482 reVive Light Therapy® Wrinkle and Acne LED Device OHS K201782 NuFace Trinity Plus Device NFO I Device Description Summary 21 CFR… | 2022 |
| * | K201782 | NuFace Trinity Plus DeviceSummary page 5…icate # Predicate Trade Name (Primary Predicate is listed first) Product Code K221443 PureLift Pro Plus NFO K223482 reVive Light Therapy® Wrinkle and Acne LED Device OHS K201782 NuFace Trinity Plus Device NFO I Device Description Summary 21 CFR 807.92(a)(4) PureLift GLOW is a hand-held dev… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K261370 | LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA)) | 2026 | 0 |
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 30 years and passes through 10 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 134 ancestors have a recall of any class.
- Of its descendants, K261370 (Guangdong Newdermo Biotech Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K221443.
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. 2025, 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?
PureLift GLOW is intended for facial and neck stimulation, treatment of wrinkles, treatment of mild to
moderate inflammatory acne, and indicated for over-the-counter cosmetic use.
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/K243587 · printed Nov 4, 2026
Cite this page
510(k) Report. “K243587: PureLift GLOW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K243587
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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