510(k) · Cleared
ClearedLumenis Smart532 Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Oct 30, 2015 as substantially equivalent to K022327 (Lumenis, Inc., 2002) and 1 other predicate after a 186-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Oct 30, 2015
- Review
- 186 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K022327 (2002). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK022327 Novus SpectraLumenis, Inc. · 2002
- This deviceK151109 Lumenis Smart532 Laser SystemLumenis, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K022327 | Novus Spectra | Lumenis, Inc. | 2002 | — |
| 0 (this device) | K151109 | Lumenis Smart532 Laser System | Lumenis, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 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 |
|---|---|---|---|
| * | K022327 | Novus SpectraSummary page 5…d plastic surgery and in dermatology III. Predicate Device Name(s): Trade Name(s): Lumenis® Novus Spectra™ Laser System (K022327) Iridex® IQ 532 Laser System (K071687) IV. Device Description:… | 2002 |
| * | K071687 | Famili of Iridex IQ Laser SystemsSummary page 5…Trade Name(s): Lumenis® Novus Spectra™ Laser System (K022327) Iridex® IQ 532 Laser System (K071687) IV. Device Description: The subject Lumenis® Smart532™ Laser System product is a dual port, solid st… | 2008 |
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?
- None of the 2 ancestors has a recall.
- 6 other devices also cite its predicate K022327.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Lumenis® Smart532™ Laser System is indicated for use in Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications as follows: Ophthalmology Diabetic Retinopathy including Macular Edema or Proliferative Retinopathy Proliferative Diabetic Retinopathy (PDR) Retinal Tear Macular Edema or Proliferative Retinopathy associated with Central Retinal Vein Occlusion (CRVO) or Branch Retinal Vein Occlusion (BRVO)…
Read the full statement (284 words)
The Lumenis® Smart532™ Laser System is indicated for use in Ophthalmic Applications; Ear, Nose and Throat Applications; Dentistry; and Dermatologic Applications as follows:
Ophthalmology
Diabetic Retinopathy including Macular Edema or Proliferative Retinopathy
Proliferative Diabetic Retinopathy (PDR)
Retinal Tear
Macular Edema or Proliferative Retinopathy associated with Central Retinal Vein Occlusion (CRVO) or Branch Retinal Vein Occlusion (BRVO)
Choroidal Neovascularization (CNV) secondary to Age-related Macular Degeneration (AMD)
Central Serous Chorioretinopathy (CSCR)
Trabeculoplasty for Primary Open Angle Glaucoma (POAG)
Iridotomy / Iridoplasty for Angle-Closure Glaucoma (ACG)
Ear, Nose and Throat (ENT)
Stapedectomy
Stapedotomy
Myringotomies
Lysis of Adhesions
Control of Bleeding
Removal of Acoustic Neuromas
Soft Tissue Adhesion in Micro/Macro Otologic procedures
Dermatology
Pigmented lesion, including soar lentigine
Vascular lesions, including cherry hemangiomas and angiokeratomas
Extremeties telangiectases, including facial and leg telangiectases
Cutaneous lesions
Flat warts
Dermatosis
Papulosa Nigra
Dentistry
Frenectomy
Treatment of oral mucous cyst
Treatment of benign vascular lesions:
Capillary hemangioma
Hemorrhagic hereditary telangiectasia
Capillary/cavernous hemangiomas
Lymphangioma
AV malformation of the tongue
Hermaniolymphangiomas
Photocoagulation of superficial vessels
Vaporization of superficial blood or lymph containing vessels
Treatment of superficial tongue lesions
Tissue management and hemostasis for crown and bridge impressions
Incision and drainage for abscess
Gingivoplasty/Gingivectomy:
Operative procedures
Crown and bridge, gingival reduction
Crown lengthening
Hyperplasia (Drug, irritation, Epulus, ...)
Hemostasis during dental procedures
Operculectomy (Operculotomy)
Excisional biopsy
Free Ginvical Graft (Adjunct):
Hemostasis of donor site
Hemostasis of graft site
Vestibuloplasty
Soften Gutta Percha
Treatment of canker sores, herpetic lesions, and aphthous ulcers
Laser-assisted bleaching/whitening
Device energy delivery options:
Energy Delivery Option Indication
SmartPulse Diabetic Retinopathy including Macular Edema or Proliferative Retinopathy, Proliferative Diabetic Retinopathy (PDR), Central Serous Chorioretinopathy (CSCR), Macular Edema or Proliferative Retinopathy associated with Branch Retinal Vein Occlusion (BRVO)
CW (Continuous Wave) All Indications
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151109 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151109: Lumenis Smart532 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/K151109
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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