510(k) Report

510(k) · Cleared

Cleared

FEATHER 01 02 03 04 (Model:01)

K251871510(k) TraditionalCleared Aug 15, 202558-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Heat IN A Click, LLC · OHS Light Based Over The Counter Wrinkle Reduction

Cleared on Aug 15, 2025 as substantially equivalent to K221444 (Light Tree Ventures Europe B.V., 2022) and 1 other predicate after a 58-day review. Its family tree reaches back 19 generations to 1995.

Decided
Aug 15, 2025
Review
58 days
Class
Class II
Product code
OHS
Recalls
None
Predicates
2

Its longest line of descent runs back 19 generations to K943450 (1995). 137 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2022: 1 other ancestor2019: 1 other ancestor2017: 3 other ancestors2018: 2 other ancestors2016: 3 other ancestors2015: 2 other ancestors2013: 3 other ancestors2012: 2 other ancestors2011: 1 other ancestor2010: 3 other ancestors2021: 1 other ancestor2008: 2 other ancestors2006: 1 other ancestor2014: 3 other ancestors2007: 2 other ancestors2005: 4 other ancestors2003: 4 other ancestors2002: 4 other ancestors2000: 6 other ancestors1998: 11 other ancestors2001: 1 other ancestor1999: 4 other ancestors1996: 12 other ancestors1995: 9 other ancestors1997: 13 other ancestors1994: 8 other ancestors1993: 3 other ancestors1991: 3 other ancestors1990: 1 other ancestor1980: 1 other ancestor1992: 3 other ancestors1985: 1 other ancestorReference device: K232977 · Biophotas Celluma CONTOUR · Biophotas, Inc. · 2023Reference device: K222377 · Led Mask Platinum Md · Cellreturn Co., Ltd. · 2022K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) ×2: 2 generations cleared close together, K964849 (1997), K971532 (1997) K974521 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1998K982816 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1999K022266 · Aurora SR · Syneron Medical, Ltd. · 2002K030426 · Omnilux Red · Photo Therapeutics Limited · 2003K081307 · Omnilux Clear-U · Photo Therapeutics, Inc. · 2009K123999 · Illumask Acne Light Therapy Mask · La Lumiere, LLC · 2013K140471 · Pro X Otc 5 · La Lumiere, LLC · 2015×2: 2 generations cleared close together, K163329 (2017), K170984 (2017) K191629 · faceLITE · Ismart Marketing Svcs, Ltd. · 2019×2: 2 generations cleared close together, K213184 (2021), K214103 (2022) ×2: 2 generations cleared close together, K230124 (2023), K230042 (2023) 19801990200020102020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors3 generations back: 4 other ancestors4 generations back: 8 other ancestors5 generations back: 7 other ancestors6 generations back: 10 other ancestors7 generations back: 11 other ancestors8 generations back: 14 other ancestors9 generations back: 25 other ancestors10 generations back: 18 other ancestors11 generations back: 14 other ancestors12 generations back: 2 other ancestors K230042 · Q-Rejuvalight Pro Facewear (Model: P19-0023) · Light Tree Ventures Europe B.V. · 2023K230124 · LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) · Light Tree Ventures Europe B.V. · 2023K214103 · Shani Darden LED light therapy mask · Harpar Grace International · 2022K213184 · MZ Skin LightMAX Supercharged LED Mask 2.0 · Mz Skin · 2021K191629 · faceLITE · Ismart Marketing Svcs, Ltd. · 2019K170984 · LG Beauty Led Mask · Lg Electronics · 2017K163329 · Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 · Pulsaderm, LLC · 2017K140471 · Pro X Otc 5 · La Lumiere, LLC · 2015K123999 · Illumask Acne Light Therapy Mask · La Lumiere, LLC · 2013K081307 · Omnilux Clear-U · Photo Therapeutics, Inc. · 2009K030426 · Omnilux Red · Photo Therapeutics Limited · 2003K022266 · Aurora SR · Syneron Medical, Ltd. · 2002K982816 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1999K974521 · Vnus Closure System · Vnus Medical Technologies, Inc. · 1998K971532 · Arthrocare Electrosurgery System · Arthrocare Corp. · 1997K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−15−10−50
  1. Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 15 generations between
  3. 3 generations backK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
  4. 2 generations backK230124 LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V. · 2023
  5. 1 generation backK230042 Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023
  6. This deviceK251871 FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC · 2025
Show all 19 generations
  1. Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 15 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
  6. 14 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
  7. 13 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
  8. 12 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
  9. 11 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
  10. 10 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
  11. 9 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
  12. 8 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
  13. 7 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
  14. 6 generations backK170984 LG Beauty Led MaskLg Electronics · 2017
  15. 5 generations backK191629 faceLITEIsmart Marketing Svcs, Ltd. · 2019
  16. 4 generations backK213184 MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin · 2021
  17. 3 generations backK214103 Shani Darden LED light therapy maskHarpar Grace International · 2022
  18. 2 generations backK230124 LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V. · 2023
  19. 1 generation backK230042 Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V. · 2023
  20. This deviceK251871 FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−19K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−18K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−17K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−16K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−15K971532Arthrocare Electrosurgery SystemArthrocare Corp.1997—
−14K974521Vnus Closure SystemVnus Medical Technologies, Inc.1998—
−13K982816Vnus Closure SystemVnus Medical Technologies, Inc.1999—
−12K022266Aurora SRSyneron Medical, Ltd.2002—
−11K030426Omnilux RedPhoto Therapeutics Limited2003—
−10K081307Omnilux Clear-UPhoto Therapeutics, Inc.2009—
−9K123999Illumask Acne Light Therapy MaskLa Lumiere, LLC2013—
−8K140471Pro X Otc 5La Lumiere, LLC2015—
−7K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC2017—
−6K170984LG Beauty Led MaskLg Electronics2017—
−5K191629faceLITEIsmart Marketing Svcs, Ltd.2019—
−4K213184MZ Skin LightMAX Supercharged LED Mask 2.0Mz Skin2021—
−3K214103Shani Darden LED light therapy maskHarpar Grace International2022—
−2K230124LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001)Light Tree Ventures Europe B.V.2023—
−1K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)Light Tree Ventures Europe B.V.2023—
0 (this device)K251871FEATHER 01 02 03 04 (Model:01)Heat IN A Click, LLC2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
198510
199010
199130
199230
199330
199480
199590
1996120
1997130
1998110
199940
200060
200110
200240
200340
200540
200610
200720
200820
201030
201110
201220
201330
201430
201520
201630
201730
201820
201910
202110
202210
FIG. 1 — Lineage of K251871, 1995–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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 OHS? 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 OHS device

  1. #1 K223544 LED light therapy mask (FM-01, FM-02, FM-03)score 48.4 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K221444LED Eye Perfector, model: EY-36A, EY-36B
Summary page 5
…tion Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Common Name: Light based over the counter wrinkle reduction 510(k) Number: K221444 Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II Predicate Devi…
Light Tree Ventures Europe B.V.2022—
*K230042Q-Rejuvalight Pro Facewear (Model: P19-0023)
Summary page 6
…1/5 Common Name: Light Based Over The Counter Wrinkle Reduction(OHS), Over-The-Counter Powered Light Based Laser For Acne(OLP) 510(k) Number: K230042 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 21 CFR 878.4810 Regulation Class: II 4. Device…
Light Tree Ventures Europe B.V.2023—
†K232977Biophotas Celluma CONTOURBiophotas, Inc.2023—
†K222377Led Mask Platinum MdCellreturn Co., Ltd.2022—

Also cleared against K221444: 1 other device →

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 30 years and passes through 13 companies; a new generation was cleared every 1.1 years on median.
  • 5 of the 137 ancestors have a recall of any class.
  • 1 other device also cites its predicate K221444.

How does its category compare?

All OHS devices

OHS Light Based Over The Counter Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · OHS

42in 2025

2008: 22010: 32011: 22012: 42013: 22014: 52015: 42016: 32017: 82018: 72019: 42020: 22021: 72022: 162023: 122024: 162025: 422026 (partial year): 26
2007high 42 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OHS

89in 2025

2010: 176 days median2012: 310 days median2014: 168 days median2015: 241 days median2016: 191 days median2017: 133 days median2018: 84 days median2019: 99 days median2021: 162 days median2022: 129 days median2023: 101 days median2024: 87 days median2025: 89 days median2026 (partial year): 88 days median
2007high 310 (2012) · low 84 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OHS

1in 2008

2008: 1
2007high 1 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OHS

34in 2025

2011: 12012: 12014: 12017: 12018: 12019: 12020: 22021: 22022: 22023: 42024: 52025: 34
2007high 34 (2025) · low 0 (2007)2025

MAUDE reports naming product code OHS, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—10
20090—00
2010317600
20112—01
2012431001
20132—00
2014516801
2015424100
2016319100
2017813301
201878401
201949901
20202—02
2021716202
20221612902
20231210104
2024168705
20254289034
202626880—

What is it indicated for?

The FEATHER 01 02 03 04 (Model: 01) is an Over the-Counter (OTC) device intended for the use in treating wrinkles on the face.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K251871: FEATHER 01 02 03 04 (Model:01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251871

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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