510(k) Report

510(k) · Cleared

Cleared

Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite, Model E-80-II, Elite Ultra, Model E-80-IV

K990174510(k) TraditionalCleared Apr 1, 199972-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

Fisma, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Apr 1, 1999 after a 72-day review. The FDA summary names its predicate without a number. 32 later devices descend from it.

Decided
Apr 1, 1999
Review
72 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

32 later devices descend from it, 3 citing it directly.

Descendants, by year cleared 2005: 2 descendants cleared2002: 1 descendant cleared2006: 3 descendants cleared2004: 1 descendant cleared2007: 1 descendant cleared2009: 1 descendant cleared2012: 1 descendant cleared2010: 2 descendants cleared2013: 3 descendants cleared2025: 2 descendants cleared2016: 2 descendants cleared2015: 1 descendant cleared2019: 4 descendants cleared2017: 1 descendant cleared2014: 2 descendants cleared2018: 1 descendant cleared2020: 1 descendant cleared2026: 2 descendants cleared2021: 1 descendant cleared1995200020052010201520202025
  1. This deviceK990174 Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite…Fisma, Inc. · 1999
  2. Descendant · cites it directly · 24 of its ownK021975 Lasersystem Beautystar 532Asclepion-Meditec AG · 2002
  3. Descendant · 2 generations on · 23 of its ownK042496 Adept Ultralite 532 LaserAdept Medical Concepts · 2004
  4. Descendant · 3 generations on · 22 of its ownK063396 Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007
  5. Descendant · 4 generations on · 20 of its ownK100143 Pilot Diode Laser, Model 002-00139CAO Group, Inc. · 2010
  6. Descendant · 5 generations on · 9 of its ownK123443 Precise SHP Diode LaserCAO Group, Inc. · 2013

Showing 5 of 32 descendants. See all descendants

Descendants cleared per year

2002: 12004: 12005: 22006: 32007: 12009: 12010: 22012: 12013: 32014: 22015: 12016: 22017: 12018: 12019: 42020: 12021: 12025: 22026: 2
2002high 4 (2019) · low 0 (2003)2026

Most influential descendants

Showing 5 of 32 · See all
  • K021975Lasersystem Beautystar 532Asclepion-Meditec AG · 2002 · cites it directly24descendants
  • K042496Adept Ultralite 532 LaserAdept Medical Concepts · 2004 · 2 generations on23descendants
  • K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L. · 2007 · 3 generations on22descendants
  • K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc. · 2010 · 4 generations on20descendants
  • K123443Precise SHP Diode LaserCAO Group, Inc. · 2013 · 5 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K990174Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite, Model…Fisma, Inc.1999—
+1K021975Lasersystem Beautystar 532Asclepion-Meditec AG2002—
+2K042496Adept Ultralite 532 LaserAdept Medical Concepts2004—
+3K063396Velure Family of Diode Lasers and Delivery Device AccessoriesLasering S.R.L.2007—
+4K100143Pilot Diode Laser, Model 002-00139CAO Group, Inc.2010—
+5K123443Precise SHP Diode LaserCAO Group, Inc.2013—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200210
200410
200520
200630
200710
200910
201020
201210
201330
201420
201510
201620
201710
201810
201940
202010
202110
202520
202620
FIG. 1 — Lineage of K990174, 1999–2026Source: 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? (3)

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
*—Continuum Biomedical, Inc., CB/Diode/532 Laser System
Named without a submission number
—
*—Laserscope, Aura Laser System
Named without a submission number
—
*—Iris Medical DioLite 532
Named without a submission number
—

What descends from it? (32)

See all 32

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

NumberDeviceApplicantDecidedDescendants
K021975Lasersystem Beautystar 532Asclepion-Meditec AG200224
K052129Lumenis 1000 Integrated Slit LampLumenis, Inc.20055
K060905Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1Iridex Corp20060

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, K021975 (Asclepion-Meditec AG, 2002) has gone furthest, with 24 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?

Ophthalmology: (Atlas-Elite, Elite Ultra) »Retinal Photocoagulation »Trabeculoplasty »Iridotomy »Diabetic Retinopathy »Peripheral Iridectomy »Posterior and Anterior procedures Ear, Nose, & Throat (ENT): 'Atlas-Elite, Elite Ultra »Stapedectomy »Stapedotomy »Myringotomies »Lysis of Adhesions »Control of Bleeding *Removal of Acoustic Neuromas »Soft Tissue Adhesion in Micro/Macro Otologic procedures *(Elite Ultra [4.0 Watt] only)* *Epistaxis (HHT)* *Partial…

Read the full statement (209 words)

Ophthalmology:

(Atlas-Elite, Elite Ultra)

»Retinal Photocoagulation

»Trabeculoplasty

»Iridotomy

»Diabetic Retinopathy

»Peripheral Iridectomy

»Posterior and Anterior procedures

Ear, Nose, & Throat (ENT):

'Atlas-Elite, Elite Ultra

»Stapedectomy

»Stapedotomy

»Myringotomies

»Lysis of Adhesions

»Control of Bleeding

*Removal of Acoustic Neuromas

»Soft Tissue Adhesion in Micro/Macro Otologic procedures

*(Elite Ultra [4.0 Watt] only)*

*Epistaxis (HHT)*

*Partial Turbinate Reduction*

*Vaporization/Coagulation of Granulation Tissue*

*Photocoagulation or Vaporization of Soft or Fibrous Tissue*

Dermatology: (Atlas-Elite, Elite Ultra, Corium 200, & Corium 400)

»Pigmented Lesions, inc. solar lentigines

»Vascular Lesions, inc. cherry hemangiomas & ongiockeratomas

»Extremities Telangiectasias, inc. facial & leg telangiectasias

»Cutaneous Lesions

»Flat Warts

»Dermatosis

»Papulosa Nigra

Dentistry

»Frenectomy

»Treatment of Oral Mucous Cysts

»Treatment of Benign Vascular Lesions:

»Capillary Hemangioma

»Hemorrhagic Hereditary Telongiectasia

»Capillary/Cavernous Hemangiomas

»*Lymphangioma

»AV Malformation of the Tongue

»Hemangiolymphangiomas

»Photocoagulation of Superficial Vessels

»Vaporization of Superficial Blood Vessels or Lymphs Containing Vessels

»Treatment of Superficial Tongue Lesions

»Tissue Management and Hemostasis for Crown end Bridge Impressions

*»Incision and Drainage for Abscess

»Gingivoplasty/Gingivectomy:

»Operative Procedures

»Crown and Bridge, Gingival Retraction

»Crown Lengthening

»Hyperplasia (Drug, Irritation, Epulis, ...)

»Hemostasis during Dental Procedures

»*Operculectomy (Operculotomy)

»Excisional Biopsy

»Free Gingival 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

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Fisma, Inc.

4 FDA decisions under this applicant name. See the company

  • K000158Veinlase, Model E50-K8-B5, Spectrum K8, Model E50-K8-B9Fisma, Inc. · 2000
  • K991464Dental 200, Dental 300, Dental 400, Models E-20, E-60, E-50Fisma, Inc. · 1999
  • K963124PC Laser with Smart Plug (PC Edo & Dental 200)Fisma, Inc. · 1996

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https://510kreport.com/device/K990174 · printed Nov 5, 2026

Cite this page

510(k) Report. “K990174: Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite, Model E-80-II, Elite Ultra, Model E-80-IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K990174

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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