510(k) · Cleared
ClearedEzlase
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biolase Technology, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Apr 14, 2009 as substantially equivalent to K070516 (Powermedic Aps, 2007) and 3 other predicates after a 130-day review. Its family tree reaches back 9 generations to 1992. 58 later devices descend from it.
- Decided
- Apr 14, 2009
- Review
- 130 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K910422 (1992). 58 ancestors in all, the oldest K871179 (1987). 58 later devices descend from it, 2 citing it directly.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 2 generations backK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- 1 generation backK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- This deviceK083595 EzlaseBiolase Technology, Inc. · 2009
- Descendant · cites it directly · 31 of its ownK121286 EPIC 10Biolase Technology, Inc. · 2012
- Descendant · cites it directly · 25 of its ownK123971 Cynosure 1064NM Diode LaserCynosure, Inc. · 2013
- Descendant · 2 generations on · 21 of its ownK170500 SIROLaser Advance+Dentsply Sirona · 2017
- Descendant · 2 generations on · 21 of its ownK150724 SculpSureCynosure, Inc. · 2015
- Descendant · 2 generations on · 21 of its ownK150230 SculpSureCynosure, Inc. · 2015
Show all 9 generations
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 7 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 6 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 5 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 4 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 3 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 2 generations backK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- 1 generation backK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- This deviceK083595 EzlaseBiolase Technology, Inc. · 2009
Showing 5 of 58 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 58 · See all- K121286EPIC 10Biolase Technology, Inc. · 2012 · cites it directly31descendants
- K123971Cynosure 1064NM Diode LaserCynosure, Inc. · 2013 · cites it directly25descendants
- K170500SIROLaser Advance+Dentsply Sirona · 2017 · 2 generations on21descendants
- K150724SculpSureCynosure, Inc. · 2015 · 2 generations on21descendants
- K150230SculpSureCynosure, Inc. · 2015 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −8 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −6 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −5 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −4 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −3 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −2 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| −1 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
| 0 (this device) | K083595 | Ezlase | Biolase Technology, Inc. | 2009 | — |
| +1 | K121286 | EPIC 10 | Biolase Technology, Inc. | 2012 | — |
| +1 | K123971 | Cynosure 1064NM Diode Laser | Cynosure, Inc. | 2013 | — |
| +2 | K170500 | SIROLaser Advance+ | Dentsply Sirona | 2017 | — |
| +2 | K150724 | SculpSure | Cynosure, Inc. | 2015 | — |
| +2 | K150230 | SculpSure | Cynosure, Inc. | 2015 | — |
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 | 7 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 8 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K070516 | PowerlaserSummary page 2…3069) to include therapeutic indications. The requested indications have already been cleared by the FDA for several equivalent medical devices, including the following: K070516 (Powerlaser), K070024 (Thor VR Single Diode Laser Treatment), K080318 (Alma Laser NIR Module) and K082707 (MedX LPT200 and LPS200… | 2007 |
| * | K070024 | Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode ProbeSummary page 2…peutic indications. The requested indications have already been cleared by the FDA for several equivalent medical devices, including the following: K070516 (Powerlaser), K070024 (Thor VR Single Diode Laser Treatment), K080318 (Alma Laser NIR Module) and K082707 (MedX LPT200 and LPS200). Based on this compa… | 2007 |
| * | K080318 | Alma Laser Nir ModuleSummary page 2…ve already been cleared by the FDA for several equivalent medical devices, including the following: K070516 (Powerlaser), K070024 (Thor VR Single Diode Laser Treatment), K080318 (Alma Laser NIR Module) and K082707 (MedX LPT200 and LPS200). Based on this comparison, the ezlaseTM is substantially equivalent… | 2008 |
| * | K082707 | Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable LaserSummary page 2…or several equivalent medical devices, including the following: K070516 (Powerlaser), K070024 (Thor VR Single Diode Laser Treatment), K080318 (Alma Laser NIR Module) and K082707 (MedX LPT200 and LPS200). Based on this comparison, the ezlaseTM is substantially equivalent in relation to previously cleared de… | 2008 |
What descends from it? (58)
See all 582 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 8 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 58 ancestors have a recall of any class.
- Of its descendants, K121286 (Biolase Technology, Inc., 2012) has gone furthest, with 31 descendants of its own.
- 3 other devices also cite its predicate K070516.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 ezlase diode system emits energy in the near-infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083595 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083595: Ezlase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083595
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