510(k) · Cleared
ClearedBioflex Professional Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meditech International, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Apr 10, 2003 as substantially equivalent to K001179 (Light Force Therapy, Inc., 2000) after a 163-day review. Its family tree reaches back 1 generation to 2000. 311 later devices descend from it.
- Decided
- Apr 10, 2003
- Review
- 163 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001179 (2000). 311 later devices descend from it, 8 citing it directly.
- Root · 1 generation backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- This deviceK023621 Bioflex Professional Therapy SystemMeditech International, Inc. · 2003
- Descendant · cites it directly · 294 of its ownK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
- Descendant · 2 generations on · 241 of its ownK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 239 of its ownK050370 Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005
- Descendant · 2 generations on · 184 of its ownK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- Descendant · 3 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
Showing 5 of 311 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 311 · See all- K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004 · cites it directly294descendants
- K042165Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · 2 generations on241descendants
- K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005 · 2 generations on239descendants
- K080318Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008 · 2 generations on184descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 3 generations on129descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| 0 (this device) | K023621 | Bioflex Professional Therapy System | Meditech International, Inc. | 2003 | — |
| +1 | K033768 | Altus Medical Optional Infrared Handpiece | Altus Medical, Inc. | 2004 | — |
| +2 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| +2 | K050370 | Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | 2005 | — |
| +2 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
| +3 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 4 | 0 |
| 2005 | 6 | 0 |
| 2006 | 4 | 0 |
| 2007 | 2 | 0 |
| 2008 | 9 | 0 |
| 2009 | 4 | 0 |
| 2010 | 4 | 0 |
| 2011 | 6 | 0 |
| 2012 | 5 | 0 |
| 2013 | 5 | 0 |
| 2014 | 8 | 0 |
| 2015 | 14 | 0 |
| 2016 | 15 | 0 |
| 2017 | 12 | 0 |
| 2018 | 16 | 0 |
| 2019 | 15 | 0 |
| 2020 | 25 | 0 |
| 2021 | 22 | 0 |
| 2022 | 30 | 0 |
| 2023 | 21 | 0 |
| 2024 | 29 | 0 |
| 2025 | 36 | 0 |
| 2026 | 19 | 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? (1)
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 |
|---|---|---|---|
| * | K001179 | Super Nova, Acubeam | 2000 |
What descends from it? (311)
See all 3118 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K033768 | Altus Medical Optional Infrared Handpiece | 2004 | 294 |
| K033986 | MLT-1000 IR Laser System | 2004 | 10 |
| K053473 | Maestro MDTL Laser System | 2006 | 8 |
| K052814 | Lumina 1600, 3300 and 6600 Systems | 2005 | 8 |
| K042256 | IR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System (Models 40, 100 and… | 2004 | 7 |
| K060134 | Apollo IR Heat Lamp System | 2006 | 1 |
| K051875 | Bioflex Prescription System and Related Treatment Heads | 2006 | 1 |
| K053201 | Curae'lase CL1000 IR Laser System | 2005 | 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?
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
The BioFfex tm Professional Therapy System is used by trained health care professionals and is
indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of
elevating tissue temperature for temporary relief of minor muscle and joint pain, arthritis, muscle
spasm, relieving stiffness and promoting relaxation of muscle tissue.
The BioFCex im Professional Therapy System is a “multi-mode” Low Level Light treatment system
configured for multiple treatment heads powered by a flexible protocol controller that delivers various
treatment protocols.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023621: Bioflex Professional Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023621
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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