510(k) · Cleared
ClearedBioflex LD-175 and LD-1200 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 Feb 24, 2005 as substantially equivalent to K033768 (Altus Medical, Inc., 2004) and 2 other predicates after a 227-day review. Its family tree reaches back 4 generations to 1987. 2 later devices descend from it.
- Decided
- Feb 24, 2005
- Review
- 227 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K871179 (1987). 19 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK871179 Opn Xii ULAragona AB Co. · 1987
- 3 generations backK982636 Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd. · 1998
- 2 generations backK022609 Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd. · 2003
- 1 generation backK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
- This deviceK041885 Bioflex LD-175 and LD-1200 Treatment HeadsMeditech International, Inc. · 2005
- Descendant · cites it directly · 1 of its ownK051875 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 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871179 | Opn Xii UL | Aragona AB Co. | 1987 | — |
| −3 | K982636 | Patient Warmer- Model PW810 | Fisher & Paykel Healthcare, Ltd. | 1998 | — |
| −2 | K022609 | Surgical Patient Warmer, Model PW820 Jhu | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| −1 | K033768 | Altus Medical Optional Infrared Handpiece | Altus Medical, Inc. | 2004 | — |
| 0 (this device) | K041885 | Bioflex LD-175 and LD-1200 Treatment Heads | Meditech International, Inc. | 2005 | — |
| +1 | 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 |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K033768 | Altus Medical Optional Infrared HandpieceSummary page 2…h International Inc. has determined that the BioFlex t"mLD-175 & LD-1200 Treatment Heads are substantially equivalent to the performance of three predicate devices: * K 033768, Optional Infrared Handpiece for CoolGlide Lasers, manufactured by Altus Medical, Inc. * K031612, Lamp, Infrared, Alt L… | 2004 |
| * | K031612 | Alt Laser, Model VTR 75Summary page 2…quivalent to the performance of three predicate devices: * K 033768, Optional Infrared Handpiece for CoolGlide Lasers, manufactured by Altus Medical, Inc. * K031612, Lamp, Infrared, Alt Laser, Model Vtr 75 manufactured by Avicenna Laser Technology, Inc. * K024179, Lamp Infrared, Palo… | 2003 |
| * | K024179 | Palomar LightcubeSummary page 2…lide Lasers, manufactured by Altus Medical, Inc. * K031612, Lamp, Infrared, Alt Laser, Model Vtr 75 manufactured by Avicenna Laser Technology, Inc. * K024179, Lamp Infrared, Palomar Lightcube, manufactured by Palomar Medical Products, This device is different from other predicate devic… | 2003 |
What descends from it? (2)
2 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 18 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 19 ancestors has a recall of any class.
- Of its descendants, K051875 (Meditech International, Inc., 2006) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K033768.
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 s LD-I75 & LD-I200 Treatment Heads are intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041885 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041885: Bioflex LD-175 and LD-1200 Treatment Heads.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041885
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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