510(k) · Cleared
ClearedInfrared Heat (Model: E0221)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Light Tree Ventures Europe B.V. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on May 16, 2023 as substantially equivalent to K171323 (Biophotas, Inc., 2017) and 1 other predicate after a 139-day review. Its family tree reaches back 14 generations to 1995. 5 later devices descend from it.
- Decided
- May 16, 2023
- Review
- 139 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 14 generations to K943450 (1995). 96 ancestors in all, the oldest K800617 (1980). 5 later devices descend from it, 3 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 2 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 1 generation backK171323 Biophotas CELLUMA3Biophotas, Inc. · 2017
- This deviceK223893 Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V. · 2023
- Descendant · cites it directly · 1 of its ownK260129 Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- Descendant · cites it directly · 1 of its ownK242151 Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69…Shenzhen Nuon Medical Equipment Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK260715 CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd. · 2026
- Descendant · cites it directly · 0 of its ownK252603 HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK251781 Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 8 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 7 generations backK022266 Aurora SRSyneron Medical, Ltd. · 2002
- 6 generations backK030426 Omnilux RedPhoto Therapeutics Limited · 2003
- 5 generations backK081307 Omnilux Clear-UPhoto Therapeutics, Inc. · 2009
- 4 generations backK123999 Illumask Acne Light Therapy MaskLa Lumiere, LLC · 2013
- 3 generations backK140471 Pro X Otc 5La Lumiere, LLC · 2015
- 2 generations backK163329 Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72Pulsaderm, LLC · 2017
- 1 generation backK171323 Biophotas CELLUMA3Biophotas, Inc. · 2017
- This deviceK223893 Infrared Heat (Model: E0221)Light Tree Ventures Europe B.V. · 2023
Most influential descendants
Showing 5 of 5 · See all- K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · cites it directly1descendant
- K242151Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)Shenzhen Nuon Medical Equipment Co., Ltd. · 2025 · cites it directly1descendant
- K260715CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)The Beauty Tech Group, Ltd. · 2026 · 2 generations on0descendants
- K252603HIGHERDOSE Body Sculptor (Model: GS-03)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · cites it directly0descendants
- K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −8 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −7 | K022266 | Aurora SR | Syneron Medical, Ltd. | 2002 | — |
| −6 | K030426 | Omnilux Red | Photo Therapeutics Limited | 2003 | — |
| −5 | K081307 | Omnilux Clear-U | Photo Therapeutics, Inc. | 2009 | — |
| −4 | K123999 | Illumask Acne Light Therapy Mask | La Lumiere, LLC | 2013 | — |
| −3 | K140471 | Pro X Otc 5 | La Lumiere, LLC | 2015 | — |
| −2 | K163329 | Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72 | Pulsaderm, LLC | 2017 | — |
| −1 | K171323 | Biophotas CELLUMA3 | Biophotas, Inc. | 2017 | — |
| 0 (this device) | K223893 | Infrared Heat (Model: E0221) | Light Tree Ventures Europe B.V. | 2023 | — |
| +1 | K260129 | Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro ) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
| +1 | K242151 | Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A… | Shenzhen Nuon Medical Equipment Co., Ltd. | 2025 | — |
| +2 | K260715 | CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) | The Beauty Tech Group, Ltd. | 2026 | — |
| +1 | K252603 | HIGHERDOSE Body Sculptor (Model: GS-03) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
| +2 | K251781 | Kala Mini 2.0 (Kala-04) | 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 | 8 | 0 |
| 1999 | 4 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 2026 | 3 | 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 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 K223544 LED light therapy mask (FM-01, FM-02, FM-03)score 48.4 · 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 |
|---|---|---|---|
| * | K171323 | Biophotas CELLUMA3Summary page 4…: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 890.5500, 21 CFR 878.4810 Regulation Class: II 3. Predicate Device Information Predicate Device (K171323) Sponsor: BioPhotas, Inc. Trade Name: BioPhotas Celluma3 Classification Name: Laser surgical instrument for use in general and pl… | 2017 |
| * | K201107 | Opera Lebody (Gold), Opera Lebody (Zafiro)Summary page 5…Code: OHS Regulation Number: 21 CFR 878.4810 1/5 K223893 Regulation Class: II Predicate Device (K201107) Sponsor: GTG Wellness Co., Ltd. Trade Name: Opera Lebody Classification Name: Laser surgical instrument for use in general and p… | 2020 |
What descends from it? (5)
3 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 28 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 96 ancestors have a recall of any class.
- Of its descendants, K260129 (Shenzhen Kaiyan Medical Equipment Co., Ltd., 2026) has gone furthest, with 1 descendant of its own.
- 6 other devices also cite its predicate K171323.
How does its category compare?
All OHS devicesOHS Light Based Over The Counter Wrinkle Reduction: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OHS
42in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OHS
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OHS
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OHS
34in 2025
MAUDE reports naming product code OHS, 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 | 2 | — | 1 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 3 | 176 | 0 | 0 |
| 2011 | 2 | — | 0 | 1 |
| 2012 | 4 | 310 | 0 | 1 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 5 | 168 | 0 | 1 |
| 2015 | 4 | 241 | 0 | 0 |
| 2016 | 3 | 191 | 0 | 0 |
| 2017 | 8 | 133 | 0 | 1 |
| 2018 | 7 | 84 | 0 | 1 |
| 2019 | 4 | 99 | 0 | 1 |
| 2020 | 2 | — | 0 | 2 |
| 2021 | 7 | 162 | 0 | 2 |
| 2022 | 16 | 129 | 0 | 2 |
| 2023 | 12 | 101 | 0 | 4 |
| 2024 | 16 | 87 | 0 | 5 |
| 2025 | 42 | 89 | 0 | 34 |
| 2026 | 26 | 88 | 0 | — |
What is it indicated for?
The Infrared Heat (Model: E0221) is intended to emit energy in the red and infrared spectrum for use in the treatment of
full face wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223893 · printed Nov 5, 2026
Cite this page
510(k) Report. “K223893: Infrared Heat (Model: E0221).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K223893
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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