510(k) · Cleared
ClearedLightLas Multi-Wavelength Medical Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lightmed Corporation · HQF Laser, Ophthalmic
Cleared on Jun 15, 2016 as substantially equivalent to K081946 (Quantel Medical, 2009) and 1 other predicate after a 271-day review. Its family tree reaches back 11 generations to 1992.
- Decided
- Jun 15, 2016
- Review
- 271 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 11 generations to K910422 (1992). 145 ancestors in all, the oldest K812219 (1981). No later device cites it as a predicate yet.
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations between
- 3 generations backK062369 Iridex Oculight TXIridex Corp · 2006
- 2 generations backK091534 Lightlas Model 532Lightmed Corp. · 2009
- 1 generation backK103547 Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp. · 2011
- This deviceK152688 LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation · 2016
Show all 11 generations
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 9 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 8 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 7 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 6 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 5 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- 4 generations backK032220 Adept 1064/532 LaserAdept Medical Concepts · 2003
- 3 generations backK062369 Iridex Oculight TXIridex Corp · 2006
- 2 generations backK091534 Lightlas Model 532Lightmed Corp. · 2009
- 1 generation backK103547 Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp. · 2011
- This deviceK152688 LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −10 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −8 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −7 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −6 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −5 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| −4 | K032220 | Adept 1064/532 Laser | Adept Medical Concepts | 2003 | — |
| −3 | K062369 | Iridex Oculight TX | Iridex Corp | 2006 | — |
| −2 | K091534 | Lightlas Model 532 | Lightmed Corp. | 2009 | — |
| −1 | K103547 | Lightlas Multi-Wavelength Medical Laser System | Lightmed Corp. | 2011 | — |
| 0 (this device) | K152688 | LightLas Multi-Wavelength Medical Laser System | Lightmed Corporation | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1983 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 3 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1993 | 7 | 0 |
| 1994 | 9 | 0 |
| 1995 | 8 | 0 |
| 1996 | 13 | 0 |
| 1997 | 11 | 0 |
| 1998 | 10 | 0 |
| 1999 | 5 | 0 |
| 2000 | 12 | 0 |
| 2001 | 14 | 0 |
| 2002 | 17 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 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 HQF? 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 HQF device
- #1 K251772 Navilas Laser System 577sl (156691)score 13.6 · 12 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 |
|---|---|---|---|
| * | K081946 | Supra Twin Ophthalmic Laser PhotocoagulatorSummary page 4…name: 21 CFR 886.4390, Class II Product code: HQF Performance Standards: 21 CFR 1040.10 & 21 CFR 1040.11 III. PREDICATE DEVICE Quantel Medical Supra Twin (K081946) LightMed Corporation LightLas 532/670 (K103547) The predicate devices have not been subject to a design-related recall.… | 2009 |
| * | K103547 | Lightlas Multi-Wavelength Medical Laser SystemSummary page 4…QF Performance Standards: 21 CFR 1040.10 & 21 CFR 1040.11 III. PREDICATE DEVICE Quantel Medical Supra Twin (K081946) LightMed Corporation LightLas 532/670 (K103547) The predicate devices have not been subject to a design-related recall. IV. DEVICE DESCRIPTION LightLas 532/810 Multi-… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 24 years and passes through 8 companies; a new generation was cleared every 2.1 years on median.
- 6 of the 145 ancestors have a recall of any class.
- 1 other device also cites its predicate K081946.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · HQF
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQF
264in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQF
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQF
106in 2025
MAUDE reports naming product code HQF, 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 | 4 | 198 | 2 | 60 |
| 2008 | 3 | 28 | 1 | 34 |
| 2009 | 7 | 115 | 2 | 33 |
| 2010 | 2 | — | 3 | 43 |
| 2011 | 4 | 128 | 5 | 26 |
| 2012 | 5 | 179 | 1 | 41 |
| 2013 | 6 | 225 | 2 | 39 |
| 2014 | 3 | 215 | 4 | 58 |
| 2015 | 4 | 295 | 0 | 80 |
| 2016 | 3 | 271 | 0 | 108 |
| 2017 | 3 | 189 | 0 | 77 |
| 2018 | 1 | — | 0 | 82 |
| 2019 | 4 | 107 | 0 | 66 |
| 2020 | 4 | 53 | 0 | 72 |
| 2021 | 1 | — | 0 | 100 |
| 2022 | 7 | 86 | 0 | 111 |
| 2023 | 5 | 155 | 0 | 92 |
| 2024 | 3 | 167 | 0 | 75 |
| 2025 | 3 | 264 | 1 | 106 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
LightLas 532/810 Multi-Wavelength Medical Laser System is intended to be used for:
• Pan-retinal photocoagulation for proliferative diabetic retinopathy- with Slitlamp or Endoprobe
• Laser retinopexy for retinal tear and detachments - with Slitlamp or Endoprobe
• Focal or grid photocoagulation for clinically significant macular edema (CSME)- with Slitlamp
• Focal photocoagulation for choroidal neovascularization (CNV) including but not limited to CNV in the setting of wet age-related macular degeneration (wet AMD)- with Slitlamp
• Trabeculoplasty for primary open angle glaucoma (POAG)- with Slitlamp
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152688: LightLas Multi-Wavelength Medical Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152688
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