510(k) Report

510(k) · Cleared

Cleared

Novus Spectra

K022327510(k) TraditionalCleared Oct 16, 200290-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Lumenis, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Oct 16, 2002 after a 90-day review. The FDA summary names its predicate without a number. 104 later devices descend from it.

Decided
Oct 16, 2002
Review
90 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

104 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2005: 3 descendants cleared2003: 1 descendant cleared2009: 2 descendants cleared2015: 5 descendants cleared2006: 4 descendants cleared2012: 4 descendants cleared2007: 1 descendant cleared2011: 5 descendants cleared2010: 3 descendants cleared2024: 12 descendants cleared2022: 9 descendants cleared2016: 8 descendants cleared2013: 7 descendants cleared2014: 5 descendants cleared2026: 3 descendants cleared2019: 3 descendants cleared2017: 4 descendants cleared2025: 14 descendants cleared2020: 3 descendants cleared2018: 2 descendants cleared2023: 4 descendants cleared2021: 2 descendants cleared200020052010201520202025
  1. This deviceK022327 Novus SpectraLumenis, Inc. · 2002
  2. Descendant · cites it directly · 75 of its ownK050562 Oculight GL/GLXIridex Corp · 2005
  3. Descendant · cites it directly · 73 of its ownK062369 Iridex Oculight TXIridex Corp · 2006
  4. Descendant · cites it directly · 72 of its ownK091534 Lightlas Model 532Lightmed Corp. · 2009
  5. Descendant · 2 generations on · 68 of its ownK100558 Quanta Diode Laser SystemQuanta System Spa · 2010
  6. Descendant · 3 generations on · 46 of its ownK102755 Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc. · 2010

Showing 5 of 104 descendants. See all descendants

Descendants cleared per year

2003: 12005: 32006: 42007: 12009: 22010: 32011: 52012: 42013: 72014: 52015: 52016: 82017: 42018: 22019: 32020: 32021: 22022: 92023: 42024: 122025: 142026: 3
2003high 14 (2025) · low 0 (2004)2026

Most influential descendants

Showing 5 of 104 · See all
  • K050562Oculight GL/GLXIridex Corp · 2005 · cites it directly75descendants
  • K062369Iridex Oculight TXIridex Corp · 2006 · cites it directly73descendants
  • K091534Lightlas Model 532Lightmed Corp. · 2009 · cites it directly72descendants
  • K100558Quanta Diode Laser SystemQuanta System Spa · 2010 · 2 generations on68descendants
  • K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD Multiwavelenght 980NM/…Biolitec, Inc. · 2010 · 3 generations on46descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022327Novus SpectraLumenis, Inc.2002—
+1K050562Oculight GL/GLXIridex Corp2005—
+1K062369Iridex Oculight TXIridex Corp2006—
+1K091534Lightlas Model 532Lightmed Corp.2009—
+2K100558Quanta Diode Laser SystemQuanta System Spa2010—
+3K102755Ceralas E/ 1470NM Fiber-Coupled Diode Laser Family; Crealas HPD…Biolitec, Inc.2010—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200530
200640
200710
200920
201030
201150
201240
201370
201450
201550
201680
201740
201820
201930
202030
202120
202290
202340
2024120
2025140
202630
FIG. 1 — Lineage of K022327, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*—Elite Solid State Green Diode Pumped 532nrn
Named without a submission number
—
*—Elite Ultra Solid State Green Diode Pumped 532nm
Named without a submission number
—
*—Corium 200 Solid State Green Diode Pumped 532nm
Named without a submission number
—
*—Corium 400 Solid State Green Diode Pumped 532nm
Named without a submission number
—

What descends from it? (104)

See all 104

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K050562Oculight GL/GLXIridex Corp200575
K062369Iridex Oculight TXIridex Corp200673
K091534Lightlas Model 532Lightmed Corp.200972
K031665Iris Medical Oculight GL/GLX Laser SystemsIridex Corp200321
K052129Lumenis 1000 Integrated Slit LampLumenis, Inc.20055
K052526Novus 3000 Laser System and Delivery DevicesLumenis, Inc.20054
K151109Lumenis Smart532 Laser SystemLumenis, Inc.20150

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?

  • Of its descendants, K050562 (Iridex Corp, 2005) has gone furthest, with 75 descendants of its own.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007: 732008: 1072009: 692010: 502011: 412012: 452013: 462014: 612015: 472016: 512017: 672018: 512019: 412020: 522021: 532022: 602023: 522024: 822025: 832026 (partial year): 57
2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007: 79 days median2008: 86 days median2009: 100 days median2010: 96 days median2011: 83 days median2012: 118 days median2013: 144 days median2014: 147 days median2015: 112 days median2016: 114 days median2017: 90 days median2018: 78 days median2019: 88 days median2020: 90 days median2021: 123 days median2022: 152 days median2023: 87 days median2024: 90 days median2025: 90 days median2026 (partial year): 90 days median
2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007: 92008: 22010: 42011: 182012: 52013: 32014: 62016: 12017: 5, 1 Class I2018: 52019: 62020: 12023: 62024: 32026 (partial year): 2
2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007: 3422008: 2322009: 2092010: 1,7112011: 3,0242012: 2,0002013: 2,2362014: 2,0362015: 2,0992016: 2,5852017: 2,9772018: 3,5252019: 2,7092020: 2,1832021: 3,4652022: 2,2882023: 2,3372024: 2,1872025: 2,720
2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200773799342
2008107862232
2009691000209
2010509641,711
20114183183,024
20124511852,000
20134614432,236
20146114762,036
20154711202,099
20165111412,585
201767905 (1)2,977
2018517853,525
2019418862,709
2020529012,183
20215312303,465
20226015202,288
2023528762,337
2024829032,187
2025839002,720
202657902—

What is it indicated for?

Ophthdmolom Retinal Photocoagulation Trabeculoplosty Iridotomy Diabetic retinopathy Peripheral Iridectomy Posterior and Anterior procedures Senile macular degeneration Eat. Nose and Throat E m Stapedectomy Stapedotomy Myringotomies Lysis of Adhesions Control of Bleeding Removal of Acoustic Neuromas Soft Tissue Adhesion in MicroMmo Otologic Proccdures Dermatolom Pigmented lesions, including soar lentgine Vascular lesions, including cherry hemangiomas and…

Read the full statement (176 words)

Ophthdmolom

Retinal Photocoagulation

Trabeculoplosty

Iridotomy

Diabetic retinopathy

Peripheral Iridectomy

Posterior and Anterior procedures

Senile macular degeneration

Eat. Nose and Throat E m

Stapedectomy

Stapedotomy

Myringotomies

Lysis of Adhesions

Control of Bleeding

Removal of Acoustic Neuromas

Soft Tissue Adhesion in MicroMmo Otologic Proccdures

Dermatolom

Pigmented lesions, including soar lentgine

Vascular lesions, including cherry hemangiomas and angiokeratomas

Extremeties telangiectasias,including facial and leg telangiectasias

Cutaneous lesions

Flat warts

Dermatosis Papulosa Nigra

Dentism

Frenectomy

Treatment of Oral Mucous Cyst

Treatment of Benign Vascular Lesions:

Capillary hemangioma

Hemorrhagic hereditary telangiectasia

Capillarykavernous hcmangbmas

Lymphangioma

AV malformation of the tongue

Hemangio1ymphangiomas

Photocoagulation of supeficial 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 (DNg. Initation, Epulus,.. .)

Hemostasis during dental procedures

Operculectomy (Operculotomy)

Excisional biopsy

Frce Ginvical Graft (Adjunct):

Hemostasis of donor site

Hemostasis of graft site

Vestibuloplasty

Soften Gutta Percha

Treatment of canker sore%, herpetic lesions, and aphthous ulcers

Laser-assisted bleachindwhitening

Indications for use as stated in the FDA summary.

More from Lumenis, Inc.

47 FDA decisions under this applicant name. See the company

  • K211979Lumenis Y&R Laser SystemLumenis, Inc. · 2022
  • K151109Lumenis Smart532 Laser SystemLumenis, Inc. · 2015
  • K130195Scanning LaserlinkLumenis, Inc. · 20131 recall
  • K111213Vision One Laser SystemLumenis, Inc. · 20111 recall
  • K100228Versapulse Model P20 Laser SystemLumenis, Inc. · 2010

Recent decisions in GEX

The GEX category page

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  • K262346CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight…Wuhan Phomed Technology Co., Ltd. · 2026
  • K261692Diode Laser Hair Removal Machine (QDTM-03)Beijing Nubway S&T Co., Ltd. · 2026

https://510kreport.com/device/K022327 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022327: Novus Spectra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022327

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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