510(k) · Cleared
Cleareddermalux Flex MD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aesthetic Technology, Ltd. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Dec 16, 2020 as substantially equivalent to K152280 (Biophotas, Inc., 2016) and 3 other predicates after a 147-day review. Its family tree reaches back 14 generations to 1995. 5 later devices descend from it.
- Decided
- Dec 16, 2020
- Review
- 147 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K943450 (1995). 146 ancestors in all, the oldest K800617 (1980). 5 later devices descend from it, 1 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK122237 Biophotas LifelightBiophotas, Inc. · 2013
- 2 generations backK131113 Biophotas CellumaBiophotas, Inc. · 2014
- 1 generation backK152280 BioPhotas Celluma3Biophotas, Inc. · 2016
- This deviceK202028 dermalux Flex MDAesthetic Technology, Ltd. · 2020
- Descendant · cites it directly · 4 of its ownK212275 Dermalux Flex MDAesthetic Technology, Ltd. · 2021
- Descendant · 2 generations on · 1 of its ownK251012 TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK260945 Ultima System (UL-800);Ultimate Face Package…Fit-Pro KFT (Ltd.) - DBA E-Fit · 2026
- Descendant · 3 generations on · 0 of its ownK260946 LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd. · 2026
- Descendant · 2 generations on · 0 of its ownK253874 LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd. · 2026
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 backK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- 4 generations backK060792 IllumimedPhotoactif, LLC · 2006
- 3 generations backK122237 Biophotas LifelightBiophotas, Inc. · 2013
- 2 generations backK131113 Biophotas CellumaBiophotas, Inc. · 2014
- 1 generation backK152280 BioPhotas Celluma3Biophotas, Inc. · 2016
- This deviceK202028 dermalux Flex MDAesthetic Technology, Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K212275Dermalux Flex MDAesthetic Technology, Ltd. · 2021 · cites it directly4descendants
- K251012TRUDERMAL Pro (ZLD-390)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · 2 generations on1descendant
- K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit · 2026 · 2 generations on0descendants
- K260946LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)Guangdong Newdermo Biotech Co., Ltd. · 2026 · 3 generations on0descendants
- K253874LED Therapy Light (COB1400, HP1800PRO)Shenzhen Hanhua Opto Co., Ltd. · 2026 · 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 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| −4 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| −3 | K122237 | Biophotas Lifelight | Biophotas, Inc. | 2013 | — |
| −2 | K131113 | Biophotas Celluma | Biophotas, Inc. | 2014 | — |
| −1 | K152280 | BioPhotas Celluma3 | Biophotas, Inc. | 2016 | — |
| 0 (this device) | K202028 | dermalux Flex MD | Aesthetic Technology, Ltd. | 2020 | — |
| +1 | K212275 | Dermalux Flex MD | Aesthetic Technology, Ltd. | 2021 | — |
| +2 | K251012 | TRUDERMAL Pro (ZLD-390) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
| +2 | K260945 | Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape… | Fit-Pro KFT (Ltd.) - DBA E-Fit | 2026 | — |
| +3 | K260946 | LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) | Guangdong Newdermo Biotech Co., Ltd. | 2026 | — |
| +2 | K253874 | LED Therapy Light (COB1400, HP1800PRO) | Shenzhen Hanhua Opto 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 | 9 | 0 |
| 1995 | 10 | 0 |
| 1996 | 12 | 0 |
| 1997 | 15 | 0 |
| 1998 | 11 | 0 |
| 1999 | 5 | 0 |
| 2000 | 10 | 0 |
| 2001 | 7 | 0 |
| 2002 | 12 | 0 |
| 2003 | 8 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 2 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2025 | 1 | 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 ILY? 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 ILY device
- #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K152280 | BioPhotas Celluma3Summary page 4…egulation Number: 21 CFR §878.4810 and §890.5500 Regulatory Class: Class II Product Code: ILY, OLP, OHS III. PREDICATE DEVICES Biophotas Celluma 3 Phototherapy System; K152280 and K171323, Biophotas Inc.; Rejuvalite MD; K133896, Trophy Skin Inc. and Opera Lebody; K201107, GTG Wellness Co. Ltd. IV. DEVI… | 2016 |
| * | K171323 | Biophotas CELLUMA3Summary page 4…mber: 21 CFR §878.4810 and §890.5500 Regulatory Class: Class II Product Code: ILY, OLP, OHS III. PREDICATE DEVICES Biophotas Celluma 3 Phototherapy System; K152280 and K171323, Biophotas Inc.; Rejuvalite MD; K133896, Trophy Skin Inc. and Opera Lebody; K201107, GTG Wellness Co. Ltd. IV. DEVICE DECRIPTIO… | 2017 |
| * | K133896 | Rejuvalite MDSummary page 4…ulatory Class: Class II Product Code: ILY, OLP, OHS III. PREDICATE DEVICES Biophotas Celluma 3 Phototherapy System; K152280 and K171323, Biophotas Inc.; Rejuvalite MD; K133896, Trophy Skin Inc. and Opera Lebody; K201107, GTG Wellness Co. Ltd. IV. DEVICE DECRIPTION The Dermalux® Flex MD is a Class II me… | 2014 |
| * | K201107 | Opera Lebody (Gold), Opera Lebody (Zafiro)Summary page 4…LP, OHS III. PREDICATE DEVICES Biophotas Celluma 3 Phototherapy System; K152280 and K171323, Biophotas Inc.; Rejuvalite MD; K133896, Trophy Skin Inc. and Opera Lebody; K201107, GTG Wellness Co. Ltd. IV. DEVICE DECRIPTION The Dermalux® Flex MD is a Class II medical device for use on a treatment bed. The… | 2020 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212275 | Dermalux Flex MD | 2021 | 4 |
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 25 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 146 ancestors have a recall of any class.
- Of its descendants, K212275 (Aesthetic Technology, Ltd., 2021) has gone furthest, with 4 descendants of its own.
- 2 other devices also cite its predicate K152280.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · ILY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ILY
116in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ILY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILY
17in 2025
MAUDE reports naming product code ILY, 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 | 10 | 128 | 0 | 24 |
| 2008 | 16 | 165 | 0 | 20 |
| 2009 | 13 | 189 | 0 | 9 |
| 2010 | 8 | 185 | 1 | 7 |
| 2011 | 9 | 198 | 0 | 10 |
| 2012 | 11 | 130 | 3 | 7 |
| 2013 | 9 | 211 | 0 | 8 |
| 2014 | 11 | 153 | 0 | 0 |
| 2015 | 11 | 146 | 0 | 2 |
| 2016 | 8 | 214 | 0 | 2 |
| 2017 | 5 | 116 | 0 | 12 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 4 | 2 |
| 2023 | 1 | — | 1 | 15 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 17 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
Intended to deliver heat in the IR spectrum to provide topical heating for the purpose of elevating tissue temperature; for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue; and to temporarily increase local blood circulation.
The blue spectrum light is intended to reduce mild to moderate inflammatory acne vulgaris.
Intended to emit energy in the red and infrared spectrum for the use in dermatology for the treatment of periorbital and full face wrinkles.
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/K202028 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202028: dermalux Flex MD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202028
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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