510(k) · Cleared
ClearedMHS Med Light 1000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Micro Health Systems, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Aug 13, 2002 after a 61-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 309 later devices descend from it.
- Decided
- Aug 13, 2002
- Review
- 61 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 0
309 later devices descend from it, 1 citing it directly.
- This deviceK021956 MHS Med Light 1000Micro Health Systems, Inc. · 2002
- Descendant · cites it directly · 308 of its ownK024179 Palomar LightcubePalomar Medical Products, Inc. · 2003
- Descendant · 2 generations on · 294 of its ownK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
- Descendant · 3 generations on · 241 of its ownK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 239 of its ownK050370 Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005
- Descendant · 3 generations on · 184 of its ownK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
Showing 5 of 309 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 309 · See all- K024179Palomar LightcubePalomar Medical Products, Inc. · 2003 · cites it directly308descendants
- K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004 · 2 generations on294descendants
- K042165Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · 3 generations on241descendants
- K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005 · 3 generations on239descendants
- K080318Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008 · 3 generations on184descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K021956 | MHS Med Light 1000 | Micro Health Systems, Inc. | 2002 | — |
| +1 | K024179 | Palomar Lightcube | Palomar Medical Products, Inc. | 2003 | — |
| +2 | K033768 | Altus Medical Optional Infrared Handpiece | Altus Medical, Inc. | 2004 | — |
| +3 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| +3 | K050370 | Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | 2005 | — |
| +3 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 5 | 0 |
| 2007 | 2 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 13 | 0 |
| 2016 | 15 | 0 |
| 2017 | 12 | 0 |
| 2018 | 16 | 0 |
| 2019 | 15 | 0 |
| 2020 | 25 | 0 |
| 2021 | 22 | 0 |
| 2022 | 31 | 0 |
| 2023 | 21 | 0 |
| 2024 | 29 | 0 |
| 2025 | 36 | 0 |
| 2026 | 19 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (309)
See all 3091 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024179 | Palomar Lightcube | 2003 | 308 |
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?
- Of its descendants, K024179 (Palomar Medical Products, Inc., 2003) has gone furthest, with 308 descendants of its own.
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 Micro Health Systems, MHS MED LIGHT 1000 is a device which helps to temporarily increase local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains through the use of heat applied in a non-contact manner. Aiming means adjustable by users from the heat ceramic filament in which there is no hazard for contacting high temperature lamps. An adjustable timer control for safety functions is also incorporated into…
Read the full statement (200 words)
The Micro Health Systems, MHS MED LIGHT 1000 is a device which helps to temporarily increase local blood circulation where applied, and temporarily relieves minor muscle and joint aches and pains through the use of heat applied in a non-contact manner. Aiming means adjustable by users from the heat ceramic filament in which there is no hazard for contacting high temperature lamps. An adjustable timer control for safety functions is also incorporated into the MHS MED LIGHT 1000. The Micro Health System MHS MED LIGHT 1000 cooling method is related to temperature of the enclosure, and the enclosure, and the enclosure temperatures of the three devices listed in the comparison table are assured. According to the different wattages and the maximum temperatures, we also know the ceramic type lamp of the AP-20 18 is more efficient that the other two lamps.
The maximum temperatures for these three devices listed in the comparison table are above 100 degrees Fahrenheit, and can reach the intended results. The timer controls and the continuous intensity controls exist on the MHS MED LIGHT 1000. The user can control the timer function and intensity control to control the receiving heat amount, thus assuming the safety level.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K021956 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021956: MHS Med Light 1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021956
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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