510(k) · Cleared
ClearedEnergyLounger (TY-01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shenzhen Kaiyan Medical Equipment Co., Ltd. · OHS Light Based Over The Counter Wrinkle Reduction
Cleared on Mar 3, 2025 as substantially equivalent to K153399 (Led Intellectual Properties, LLC, 2016) and 2 other predicates after a 243-day review. Its family tree reaches back 19 generations to 1995. 1 later device descends from it.
- Decided
- Mar 3, 2025
- Review
- 243 days
- Class
- Class II
- Product code
- OHS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 19 generations to K943450 (1995). 192 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
- 2 generations backK202955 Contour Light CL-100Contour Research, LLC · 2021
- 1 generation backK232977 Biophotas Celluma CONTOURBiophotas, Inc. · 2023
- This deviceK241947 EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK260688 Sculpt LED Belt…Shenzhen Kaiyan Medical Equipment 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 backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 7 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 6 generations backK061603 SmoothshapesBiocellulase, Inc. · 2006
- 5 generations backK101366 I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010
- 4 generations backK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
- 3 generations backK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
- 2 generations backK202955 Contour Light CL-100Contour Research, LLC · 2021
- 1 generation backK232977 Biophotas Celluma CONTOURBiophotas, Inc. · 2023
- This deviceK241947 EnergyLounger (TY-01)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · cites it directly0descendants
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 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −7 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
| −6 | K061603 | Smoothshapes | Biocellulase, Inc. | 2006 | — |
| −5 | K101366 | I-Lipo, Models A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | 2010 | — |
| −4 | K111501 | I-Lipo System | Chromogenex Technologies Limited | 2012 | — |
| −3 | K130341 | Strawberry, Strawberry & Cream | Laser Lipo Limited | 2013 | — |
| −2 | K202955 | Contour Light CL-100 | Contour Research, LLC | 2021 | — |
| −1 | K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | 2023 | — |
| 0 (this device) | K241947 | EnergyLounger (TY-01) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
| +1 | K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 14 | 0 |
| 1997 | 17 | 0 |
| 1998 | 10 | 0 |
| 1999 | 6 | 0 |
| 2000 | 12 | 0 |
| 2001 | 8 | 0 |
| 2002 | 15 | 0 |
| 2003 | 10 | 0 |
| 2004 | 5 | 0 |
| 2005 | 8 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 2 | 0 |
| 2010 | 4 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 5 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 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? (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 |
|---|---|---|---|
| * | K153399 | LightStim Professional LED BedSummary page 5…Product Code: OHS, ILY, OLI Regulation Number: 21 CFR 878.4810, 21 CFR 890.5500, 21CFR 878 5400 Regulation Class: II 3. Predicate Device Information Predicate Device 1 (K153399) Sponsor: LED Intellectual Properties, LLC Trade Name: LightStim Professional LED Bed Classification Name: Infrared Lamp, Therape… | 2016 |
| * | K232977 | Biophotas Celluma CONTOURSummary page 5…n Name: Infrared Lamp, Therapeutic Heating Review Panel: Physical Medicine Product Code: ILY Regulation Number: 21 CFR 890.5500 Regulation Class: II Predicate Device 2 (K232977) Sponsor: Biophotas Inc Trade Name: Biophotas Celluma CONTOUR Classification Name: Light based over the counter wrinkle reduction… | 2023 |
| * | K223147 | myLEDmaskSummary page 6…1 / 6 Regulation Number: 21 CFR 878.5400, 21 CFR 890.5500, 21 CFR 878.4810 Regulation Class: II Predicate Device 3 (K223147) Sponsor: MyBlend Trade Name: MyLedMAsk Classification Name: Light based over the counter wrinkle reduction Review Panel: General… | 2023 |
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 |
|---|---|---|---|
| K260688 | Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C) | 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 11 companies; a new generation was cleared every 1.2 years on median.
- 6 of the 192 ancestors have a recall of any class.
- Of its descendants, K260688 (Shenzhen Kaiyan Medical Equipment Co., Ltd., 2026) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K153399.
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. 2025, 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?
M1 is used to reduce the circumference of the hips, waist and thighs and is indicated for use as a noninvasive dermatological.
M2 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.
M3 is intended to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis, pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K241947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241947: EnergyLounger (TY-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241947
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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