510(k) · Cleared
ClearedBioflex Prescription System and Related Treatment Heads
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 Mar 13, 2006 as substantially equivalent to K023621 (Meditech International, Inc., 2003) and 1 other predicate after a 245-day review. Its family tree reaches back 5 generations to 1987. 1 later device descends from it.
- Decided
- Mar 13, 2006
- Review
- 245 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K871179 (1987). 20 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK871179 Opn Xii ULAragona AB Co. · 1987
- 4 generations backK982636 Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd. · 1998
- 3 generations backK022609 Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd. · 2003
- 2 generations backK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
- 1 generation backK041885 Bioflex LD-175 and LD-1200 Treatment HeadsMeditech International, Inc. · 2005
- This deviceK051875 Bioflex Prescription System and Related Treatment HeadsMeditech International, Inc. · 2006
- Descendant · cites it directly · 0 of its ownK081355 Bioflex LD-R100 Treatment HeadMeditech International, Inc. · 2008
Most influential descendants
Showing 1 of 1 · See all- K081355Bioflex LD-R100 Treatment HeadMeditech International, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K871179 | Opn Xii UL | Aragona AB Co. | 1987 | — |
| −4 | K982636 | Patient Warmer- Model PW810 | Fisher & Paykel Healthcare, Ltd. | 1998 | — |
| −3 | K022609 | Surgical Patient Warmer, Model PW820 Jhu | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| −2 | K033768 | Altus Medical Optional Infrared Handpiece | Altus Medical, Inc. | 2004 | — |
| −1 | K041885 | Bioflex LD-175 and LD-1200 Treatment Heads | Meditech International, Inc. | 2005 | — |
| 0 (this device) | K051875 | Bioflex Prescription System and Related Treatment Heads | Meditech International, Inc. | 2006 | — |
| +1 | K081355 | Bioflex LD-R100 Treatment Head | Meditech International, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 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? (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 |
|---|---|---|---|
| * | K023621 | Bioflex Professional Therapy SystemSummary page 2…tem consisted of four low level light therapy (LLLT) treatment heads (LEDs) powered by an electronic control unit that was driven by a P.C. using software, K023621 (completed in 10 April 2003). * BioFlex t' LD-175 & LD-1200 Treatment Heads consists of two laser diode treatment heads… | 2003 |
| * | K041885 | Bioflex LD-175 and LD-1200 Treatment HeadsSummary page 2…ment heads that were designed to work with the BioFlexim Professional System. These laser diode treatment heads were determined substantially equivalent in K041885 (completed on February 24 t ', 2005). A series of factory calibration tests are conducted to verify the device is accurat… | 2005 |
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 |
|---|---|---|---|
| K081355 | Bioflex LD-R100 Treatment Head | 2008 | 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 19 years and passes through 4 companies; a new generation was cleared every 1.0 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K081355 (Meditech International, Inc., 2008) has gone furthest, with 0 descendants of its own.
- 7 other devices also cite its predicate K023621.
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 BioFlex"" Prescription Unit and related Treatment Heads is used by trained health care professionals and is indicated for the 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 BioFlex"" Prescription Unit and related Treatment Heads is a "multi-mode" low level light treatment system configured for multiple treatment heads and powered by a flexible protocol controller that delivers various treatment protocols.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051875 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051875: Bioflex Prescription System and Related Treatment Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051875
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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