510(k) · Cleared
ClearedAlma Laser Nir Module
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alma Lasers, Ltd. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Mar 7, 2008 as substantially equivalent to K050370 (Palomar Medical Technologies, Inc., 2005) and 2 other predicates after a 30-day review. Its family tree reaches back 8 generations to 1992. 184 later devices descend from it.
- Decided
- Mar 7, 2008
- Review
- 30 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K910422 (1992). 48 ancestors in all, the oldest K871179 (1987). 184 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 6 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 5 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 4 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 3 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 2 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 1 generation backK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- This deviceK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- Descendant · cites it directly · 124 of its ownK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
- Descendant · 2 generations on · 118 of its ownK112031 Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for…Alma Lasers, Inc. · 2011
- Descendant · cites it directly · 58 of its ownK083595 EzlaseBiolase Technology, Inc. · 2009
- Descendant · cites it directly · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- Descendant · 3 generations on · 53 of its ownK123483 Diode LaserBeijing Syntech Laser CO., LTD. · 2013
Showing 5 of 184 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 184 · See all- K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010 · cites it directly124descendants
- K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc. · 2011 · 2 generations on118descendants
- K083595EzlaseBiolase Technology, Inc. · 2009 · cites it directly58descendants
- K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · cites it directly57descendants
- K123483Diode LaserBeijing Syntech Laser CO., LTD. · 2013 · 3 generations on53descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −7 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −5 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −4 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −3 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −2 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −1 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| 0 (this device) | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
| +1 | K102716 | Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms | Alma Lasers, Inc. | 2010 | — |
| +2 | K112031 | Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with… | Alma Lasers, Inc. | 2011 | — |
| +1 | K083595 | Ezlase | Biolase Technology, Inc. | 2009 | — |
| +1 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| +3 | K123483 | Diode Laser | Beijing Syntech Laser CO., LTD. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 8 | 0 |
| 2016 | 9 | 0 |
| 2017 | 6 | 0 |
| 2018 | 9 | 0 |
| 2019 | 13 | 0 |
| 2020 | 18 | 0 |
| 2021 | 15 | 0 |
| 2022 | 22 | 0 |
| 2023 | 15 | 0 |
| 2024 | 20 | 0 |
| 2025 | 23 | 0 |
| 2026 | 14 | 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 |
|---|---|---|---|
| * | K050370 | Palomar Luxir HandpieceSummary page 1…Alma Lasers NIR Module Primary Classification Names: Lamp, Infrared, Therapeutic Heating III. Predicate Devices * K050370 -Palomar LuxlR Handpiece -Palomar Medical Technologies, Inc. * K042 165 - Cutera Titan Tabletop Product -Cutera,lInc.… | 2005 |
| * | K042165 | Cutera Tabletop Aesthetic ProductSummary page 1…Lamp, Infrared, Therapeutic Heating III. Predicate Devices * K050370 -Palomar LuxlR Handpiece -Palomar Medical Technologies, Inc. * K042 165 - Cutera Titan Tabletop Product -Cutera,lInc. * K033768 - Altus Medical Optional Infrared H-andpiece - Cutera, Inc. (… | 2004 |
| * | K033768 | Altus Medical Optional Infrared HandpieceSummary page 1…es * K050370 -Palomar LuxlR Handpiece -Palomar Medical Technologies, Inc. * K042 165 - Cutera Titan Tabletop Product -Cutera,lInc. * K033768 - Altus Medical Optional Infrared H-andpiece - Cutera, Inc. (cleared under the former company name of Altus Medical… | 2004 |
What descends from it? (184)
See all 1843 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 16 years and passes through 7 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 48 ancestors have a recall of any class.
- Of its descendants, K102716 (Alma Lasers, Inc., 2010) has gone furthest, with 124 descendants of its own.
- 2 other devices also cite its predicate K050370.
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 Alma Lasers NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief of minor muscle pain 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; 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/K080318 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080318: Alma Laser Nir Module.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080318
Report an extraction error
Are you the manufacturer?
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