510(k) · Cleared
ClearedAltus Medical Optional Infrared Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Altus Medical, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Feb 17, 2004 as substantially equivalent to K001056 (Olympic Medical Corp., 2000) and 3 other predicates after a 76-day review. Its family tree reaches back 3 generations to 1987. 294 later devices descend from it.
- Decided
- Feb 17, 2004
- Review
- 76 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K871179 (1987). 16 ancestors in all. 294 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK871179 Opn Xii ULAragona AB Co. · 1987
- 2 generations backK982636 Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd. · 1998
- 1 generation backK022609 Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd. · 2003
- This deviceK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
- Descendant · cites it directly · 241 of its ownK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- Descendant · cites it directly · 239 of its ownK050370 Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005
- Descendant · cites it directly · 184 of its ownK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- Descendant · 2 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- Descendant · 2 generations on · 124 of its ownK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
Showing 5 of 294 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 294 · See all- K042165Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · cites it directly241descendants
- K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005 · cites it directly239descendants
- K080318Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008 · cites it directly184descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 2 generations on129descendants
- K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010 · 2 generations on124descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K871179 | Opn Xii UL | Aragona AB Co. | 1987 | — |
| −2 | K982636 | Patient Warmer- Model PW810 | Fisher & Paykel Healthcare, Ltd. | 1998 | — |
| −1 | K022609 | Surgical Patient Warmer, Model PW820 Jhu | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| 0 (this device) | K033768 | Altus Medical Optional Infrared Handpiece | Altus Medical, Inc. | 2004 | — |
| +1 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| +1 | K050370 | Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | 2005 | — |
| +1 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
| +2 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| +2 | K102716 | Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms | Alma Lasers, Inc. | 2010 | — |
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 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 8 | 0 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 5 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 7 | 0 |
| 2015 | 12 | 0 |
| 2016 | 15 | 0 |
| 2017 | 11 | 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? (4)
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 |
|---|---|---|---|
| * | K001056 | Olympic Warm-UPSummary page 1…ame: Infrared Lamp - product code 89 ILY; class I1; 890.5500 Common Name: Infrared lamp 11. Predicate Devices * K001056- Olympic Warm-up by Olympic Medical · K022609 - PW820 Patient Warmer by Fisher & Paykel * K023621 - BioFlex… | 2000 |
| * | K022609 | Surgical Patient Warmer, Model PW820 JhuSummary page 1…; 890.5500 Common Name: Infrared lamp 11. Predicate Devices * K001056- Olympic Warm-up by Olympic Medical · K022609 - PW820 Patient Warmer by Fisher & Paykel * K023621 - BioFlex Professional Therapy System by Meditech International… | 2003 |
| * | K023621 | Bioflex Professional Therapy SystemSummary page 1…ed lamp 11. Predicate Devices * K001056- Olympic Warm-up by Olympic Medical · K022609 - PW820 Patient Warmer by Fisher & Paykel * K023621 - BioFlex Professional Therapy System by Meditech International * K024179 - Thermapulse by Palomar Medical Technologie… | 2003 |
| * | K024179 | Palomar LightcubeSummary page 1…Medical · K022609 - PW820 Patient Warmer by Fisher & Paykel * K023621 - BioFlex Professional Therapy System by Meditech International * K024179 - Thermapulse by Palomar Medical Technologies, Inc. IV. Product Description/Technological Characteristics The opti… | 2003 |
What descends from it? (294)
See all 2944 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 17 years and passes through 3 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 16 ancestors has a recall of any class.
- Of its descendants, K042165 (Cutera, Inc., 2004) has gone furthest, with 241 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 Altus Medical optional infrared handpiece is intended to emit energy in the 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, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Altus Medical optional infrared handpiece may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033768 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033768: Altus Medical Optional Infrared Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033768
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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