510(k) · Cleared
ClearedLapex BCS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Meridian Co., Ltd. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Dec 29, 2008 as substantially equivalent to K033923 (Thor Intl., 2004) and 1 other predicate after a 173-day review. Its family tree reaches back 1 generation to 2004. 19 later devices descend from it.
- Decided
- Dec 29, 2008
- Review
- 173 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K033923 (2004). 2 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK033923 TH0R Ddii IR Lamp SystemThor Intl. · 2004
- This deviceK081962 Lapex BCSMeridian Co., Ltd. · 2008
- Descendant · cites it directly · 16 of its ownK101366 I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010
- Descendant · 2 generations on · 15 of its ownK111501 I-Lipo SystemChromogenex Technologies Limited · 2012
- Descendant · 3 generations on · 12 of its ownK130341 Strawberry, Strawberry & CreamLaser Lipo Limited · 2013
- Descendant · 4 generations on · 8 of its ownK202955 Contour Light CL-100Contour Research, LLC · 2021
- Descendant · 5 generations on · 5 of its ownK232977 Biophotas Celluma CONTOURBiophotas, Inc. · 2023
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K101366I-Lipo, Models A00-1238 (230V), A00-1239 (120V)Chromogenex Technologies, Ltd. · 2010 · cites it directly16descendants
- K111501I-Lipo SystemChromogenex Technologies Limited · 2012 · 2 generations on15descendants
- K130341Strawberry, Strawberry & CreamLaser Lipo Limited · 2013 · 3 generations on12descendants
- K202955Contour Light CL-100Contour Research, LLC · 2021 · 4 generations on8descendants
- K232977Biophotas Celluma CONTOURBiophotas, Inc. · 2023 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033923 | TH0R Ddii IR Lamp System | Thor Intl. | 2004 | — |
| 0 (this device) | K081962 | Lapex BCS | Meridian Co., Ltd. | 2008 | — |
| +1 | K101366 | I-Lipo, Models A00-1238 (230V), A00-1239 (120V) | Chromogenex Technologies, Ltd. | 2010 | — |
| +2 | K111501 | I-Lipo System | Chromogenex Technologies Limited | 2012 | — |
| +3 | K130341 | Strawberry, Strawberry & Cream | Laser Lipo Limited | 2013 | — |
| +4 | K202955 | Contour Light CL-100 | Contour Research, LLC | 2021 | — |
| +5 | K232977 | Biophotas Celluma CONTOUR | Biophotas, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 4 | 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 |
|---|---|---|---|
| * | K033923 | TH0R Ddii IR Lamp SystemSummary page 1…ally marketed devices: The LAPEX BCS is substantially equivalent to other infrared lamps currently in commercial distribution such as the THOR DDII IR lamp System (K033923), THOR International Ltd., and Vectra Genisys Laser System (Intelect XT Laser System) (K040662), Chattanooga Group. The LAPEX… | 2004 |
| * | K040662 | Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser…Summary page 1…tly in commercial distribution such as the THOR DDII IR lamp System (K033923), THOR International Ltd., and Vectra Genisys Laser System (Intelect XT Laser System) (K040662), Chattanooga Group. The LAPEX BCS has same intended use as and similar technological characteristics to these predicate devic… | 2004 |
What descends from it? (19)
See all 193 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?
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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?
The LAPEX BCS is intended to emit energy in the visible and infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081962: Lapex BCS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081962
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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