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 Corp. · HQF Laser, Ophthalmic
Cleared on Nov 3, 2011 as substantially equivalent to K052777 (Ellex Medical Pty, Ltd., 2006) and 3 other predicates after a 336-day review. Its family tree reaches back 10 generations to 1992. 2 later devices descend from it.
- Decided
- Nov 3, 2011
- Review
- 336 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K910422 (1992). 133 ancestors in all, the oldest K812219 (1981). 2 later devices descend from it, 2 citing it directly.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK032220 Adept 1064/532 LaserAdept Medical Concepts · 2003
- 2 generations backK062369 Iridex Oculight TXIridex Corp · 2006
- 1 generation backK091534 Lightlas Model 532Lightmed Corp. · 2009
- This deviceK103547 Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp. · 2011
- Descendant · cites it directly · 0 of its ownK152688 LightLas Multi-Wavelength Medical Laser SystemLightmed Corporation · 2016
- Descendant · cites it directly · 0 of its ownK124043 Lightlas Family of Multi-Wavelength Medical Laser SystemLightmed Corp. · 2013
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 4 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- 3 generations backK032220 Adept 1064/532 LaserAdept Medical Concepts · 2003
- 2 generations backK062369 Iridex Oculight TXIridex Corp · 2006
- 1 generation backK091534 Lightlas Model 532Lightmed Corp. · 2009
- This deviceK103547 Lightlas Multi-Wavelength Medical Laser SystemLightmed Corp. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −4 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| −3 | K032220 | Adept 1064/532 Laser | Adept Medical Concepts | 2003 | — |
| −2 | K062369 | Iridex Oculight TX | Iridex Corp | 2006 | — |
| −1 | K091534 | Lightlas Model 532 | Lightmed Corp. | 2009 | — |
| 0 (this device) | K103547 | Lightlas Multi-Wavelength Medical Laser System | Lightmed Corp. | 2011 | — |
| +1 | K152688 | LightLas Multi-Wavelength Medical Laser System | Lightmed Corporation | 2016 | — |
| +1 | K124043 | Lightlas Family of Multi-Wavelength Medical Laser System | Lightmed Corp. | 2013 | — |
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 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1993 | 6 | 0 |
| 1994 | 9 | 0 |
| 1995 | 8 | 0 |
| 1996 | 13 | 0 |
| 1997 | 11 | 0 |
| 1998 | 10 | 0 |
| 1999 | 5 | 0 |
| 2000 | 12 | 0 |
| 2001 | 13 | 0 |
| 2002 | 15 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 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? (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 |
|---|---|---|---|
| * | K052777 | Laserex Duo Family of Dual Wavelength Ophthalmic Lasers Including Models Integre Duo…Summary page 1…and in dermatology Regulatory Class: 11 Performance standards: 21 CFR 1040.10 & 1040.11 C. Predicate Device Names: (1) Ellex Integre Duo (K052777) (2) Lumenis Nevus@ Varia'M Ophthalmic Laser and Delivery Devices (K02218 1) (3) Nidek Multi Color Laser Photocoagula… | 2006 |
| * | K022181 | Novus Varia Ophthalmic Laser and Delivery Devices with AccessoriesSummary page 1…s: 21 CFR 1040.10 & 1040.11 C. Predicate Device Names: (1) Ellex Integre Duo (K052777) (2) Lumenis Nevus@ Varia'M Ophthalmic Laser and Delivery Devices (K02218 1) (3) Nidek Multi Color Laser Photocoagulator Model MC-300 (K(042785) (4) LightMed Lightlas532 (K(091534) D. Device… | 2002 |
| * | K042785 | Multi Color Laser Photocoagulator, Model MC-300Summary page 2…ophthalmic lasers, LightLas 532/670, has the same intended use, general design and fundamental scientific technology as the predicate devices (K052777, K02218], K042785, and K091534). Also the operating controls and functions are equivalent to these products. They have the same functional… | 2004 |
| * | K091534 | Lightlas Model 532Summary page 2…asers, LightLas 532/670, has the same intended use, general design and fundamental scientific technology as the predicate devices (K052777, K02218], K042785, and K091534). Also the operating controls and functions are equivalent to these products. They have the same functional elements such… | 2009 |
What descends from it? (2)
2 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 19 years and passes through 7 companies; a new generation was cleared every 2.1 years on median.
- 5 of the 133 ancestors have a recall of any class.
- Of its descendants, K152688 (Lightmed Corporation, 2016) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K052777.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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?
Ophthalmology:
532nim Laser
* Retinal Photocoagulation
* Pan Retinal Photocoagulation
* Endophotocoagulation
* Macular photocoagulation to treat leaking vessels
* Laser Trabeculoplasty
670nm Laser
* Retinal/Pan Retinal Photocoagulation
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103547 · printed Nov 5, 2026
Cite this page
510(k) Report. “K103547: Lightlas Multi-Wavelength Medical Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103547
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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