510(k) · Cleared
ClearedLightlas Model 532
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lightmed Corp. · HQF Laser, Ophthalmic
Cleared on Sep 18, 2009 as substantially equivalent to K022327 (Lumenis, Inc., 2002) and 3 other predicates after a 115-day review. Its family tree reaches back 9 generations to 1992. 72 later devices descend from it.
- Decided
- Sep 18, 2009
- Review
- 115 days
- Class
- Class II
- Product code
- HQF
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 9 generations to K910422 (1992). 113 ancestors in all, the oldest K820106 (1982). 72 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 backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- 2 generations backK032220 Adept 1064/532 LaserAdept Medical Concepts · 2003
- 1 generation backK062369 Iridex Oculight TXIridex Corp · 2006
- This deviceK091534 Lightlas Model 532Lightmed Corp. · 2009
- Descendant · cites it directly · 68 of its ownK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
- Descendant · 2 generations on · 46 of its ownK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010
- Descendant · 3 generations on · 26 of its ownK110080 Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011
- Descendant · 4 generations on · 24 of its ownK120810 Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012
- Descendant · 4 generations on · 23 of its ownK124003 Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes…Med-Fibers, Inc. · 2013
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 backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 4 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 3 generations backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- 2 generations backK032220 Adept 1064/532 LaserAdept Medical Concepts · 2003
- 1 generation backK062369 Iridex Oculight TXIridex Corp · 2006
- This deviceK091534 Lightlas Model 532Lightmed Corp. · 2009
Showing 5 of 72 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 72 · See all- K100558Quanta Diode Laser SystemQuanta System Spa · 2010 · cites it directly68descendants
- K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc. · 2010 · 2 generations on46descendants
- K110080Radial-Emitting Shaped Fiber Optic Delivery SystemBiolitec, Inc. · 2011 · 3 generations on26descendants
- K120810Fiberoptic Laser Delivery SystemFiberoptic Fabrications, Inc. · 2012 · 4 generations on24descendants
- K124003Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers End- and…Med-Fibers, Inc. · 2013 · 4 generations on23descendants
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 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −4 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −3 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| −2 | K032220 | Adept 1064/532 Laser | Adept Medical Concepts | 2003 | — |
| −1 | K062369 | Iridex Oculight TX | Iridex Corp | 2006 | — |
| 0 (this device) | K091534 | Lightlas Model 532 | Lightmed Corp. | 2009 | — |
| +1 | K100558 | Quanta Diode Laser System | Quanta System Spa | 2010 | — |
| +2 | K102755 | Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD… | Biolitec, Inc. | 2010 | — |
| +3 | K110080 | Radial-Emitting Shaped Fiber Optic Delivery System | Biolitec, Inc. | 2011 | — |
| +4 | K120810 | Fiberoptic Laser Delivery System | Fiberoptic Fabrications, Inc. | 2012 | — |
| +4 | K124003 | Med-Fibers Surgical Laser Fiber, Med-Fibers Endo-Ent Laser Probes, Med-Fibers… | Med-Fibers, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 9 | 0 |
| 1997 | 11 | 0 |
| 1998 | 9 | 0 |
| 1999 | 4 | 0 |
| 2000 | 11 | 0 |
| 2001 | 13 | 0 |
| 2002 | 14 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 7 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 8 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 9 | 0 |
| 2025 | 13 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K022327 | Novus SpectraSummary page 1…logy Regulatory Class: II Performance standards: 21 CFR 1040.10 & 1040.11 C. Predicate Device Names: (1) Device Names: Novus Spectra Laser System (K022327) (2) Device Names: Viridis Derma(K020071) (3) Device Nambe: VariLite Laser System (K041930) 510K_ENTA4.doc… | 2002 |
| * | K020071 | Viridis Derma LaserSummary page 1…Performance standards: 21 CFR 1040.10 & 1040.11 C. Predicate Device Names: (1) Device Names: Novus Spectra Laser System (K022327) (2) Device Names: Viridis Derma(K020071) (3) Device Nambe: VariLite Laser System (K041930) 510K_ENTA4.doc… | 2002 |
| * | K041930 | Varilite Laser SystemSummary page 1…C. Predicate Device Names: (1) Device Names: Novus Spectra Laser System (K022327) (2) Device Names: Viridis Derma(K020071) (3) Device Nambe: VariLite Laser System (K041930) 510K_ENTA4.doc 64 D. Device Descripti… | 2004 |
| * | K062369 | Iridex Oculight TXSummary page 2…gical Characteristics summary & Substantial Equivalence The Medical Frequency Doubled YAG Laser has the same indications for use as the Irides-OcuLight TX (K062369). They have similar functional elements such as treatment wavelengths, pulse rates, treatment power, spot size and cooling… | 2006 |
What descends from it? (72)
See all 722 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 7 companies; a new generation was cleared every 1.7 years on median.
- 3 of the 113 ancestors have a recall of any class.
- Of its descendants, K100558 (Quanta System Spa, 2010) has gone furthest, with 68 descendants of its own.
- 6 other devices also cite its predicate K022327.
How does its category compare?
All HQF devicesHQF Laser, Ophthalmic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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:
Retinal Photocoagulation
Pan Retinal Photocoagulation
Endophotocoagulation
Macular Treatments
Laser Trabeculoplasty
Otolaryngology:
Stapedectomy
Stapedotomy
Myringotomy
Lysis of adhesions
Control of bleeding
Removal of acoustic neuromas
Soft tissue adhesion in micro/macro otologic procedures.
Dermatology:
Vascular lesion
Pigmented lesion
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091534 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091534: Lightlas Model 532.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091534
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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