510(k) Report

510(k) · Cleared

Cleared

Combination ND:Yag and Frequency Doubled Solid State Green Laser

K981952510(k) TraditionalCleared Sep 1, 199890-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

Instruments For Medicine and Diagnostics · GEX Powered Laser Surgical Instrument

Cleared on Sep 1, 1998 after a 90-day review. The FDA summary names its predicate without a number. 763 later devices descend from it.

Decided
Sep 1, 1998
Review
90 days
Class
Class II
Product code
GEX
Recalls
None
Predicates
0

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

Descendants, by year cleared 2005: 9 descendants cleared2002: 6 descendants cleared2007: 16 descendants cleared2000: 1 descendant cleared1999: 1 descendant cleared2003: 7 descendants cleared2016: 40 descendants cleared2025: 84 descendants cleared2022: 55 descendants cleared2006: 9 descendants cleared2011: 25 descendants cleared2008: 28 descendants cleared2009: 17 descendants cleared2014: 32 descendants cleared2004: 8 descendants cleared2010: 19 descendants cleared2015: 27 descendants cleared2013: 30 descendants cleared2018: 34 descendants cleared2020: 42 descendants cleared2012: 23 descendants cleared2017: 33 descendants cleared2023: 43 descendants cleared2019: 24 descendants cleared2021: 32 descendants cleared2024: 71 descendants cleared2026: 47 descendants cleared1995200020052010201520202025
  1. This deviceK981952 Combination ND:Yag and Frequency Doubled Solid State Green LaserInstruments For Medicine and Diagnostics · 1998
  2. Descendant · cites it directly · 755 of its ownK991234 The Acme Medical Aesthetic ND:Yag LaserAcme Medical, Inc. · 1999
  3. Descendant · cites it directly · 739 of its ownK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
  4. Descendant · cites it directly · 700 of its ownK993671 Candela Sclero Long Pulse Dye LaserCandela Corp. · 2000
  5. Descendant · 2 generations on · 699 of its ownK013748 Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002
  6. Descendant · 2 generations on · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002

Showing 5 of 763 descendants. See all descendants

Descendants cleared per year

1999: 12000: 12002: 62003: 72004: 82005: 92006: 92007: 162008: 282009: 172010: 192011: 252012: 232013: 302014: 322015: 272016: 402017: 332018: 342019: 242020: 422021: 322022: 552023: 432024: 712025: 842026: 47
1999high 84 (2025) · low 0 (2001)2026

Most influential descendants

Showing 5 of 763 · See all
  • K991234The Acme Medical Aesthetic ND:Yag LaserAcme Medical, Inc. · 1999 · cites it directly755descendants
  • K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc. · 2002 · cites it directly739descendants
  • K993671Candela Sclero Long Pulse Dye LaserCandela Corp. · 2000 · cites it directly700descendants
  • K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002 · 2 generations on699descendants
  • K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · 2 generations on665descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K981952Combination ND:Yag and Frequency Doubled Solid State Green LaserInstruments For Medicine and Diagnostics1998—
+1K991234The Acme Medical Aesthetic ND:Yag LaserAcme Medical, Inc.1999—
+1K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide…Altus Medical, Inc.2002—
+1K993671Candela Sclero Long Pulse Dye LaserCandela Corp.2000—
+2K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp.2002—
+2K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II…Altus Medical, Inc.2002—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200010
200260
200370
200480
200590
200690
2007160
2008280
2009170
2010190
2011250
2012230
2013300
2014320
2015270
2016400
2017330
2018340
2019240
2020420
2021320
2022550
2023430
2024710
2025840
2026470
FIG. 1 — Lineage of K981952, 1998–2026Source: 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
*—Coherent VersaPulse
Named without a submission number
—
*—Thermolase Softlight Laser
Named without a submission number
—
*—Laserscope Orion Series Laser System
Named without a submission number
—
*—Cynosure PhotoGenica LPIR Laser
Named without a submission number
—

What descends from it? (763)

See all 763

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

NumberDeviceApplicantDecidedDescendants
K991234The Acme Medical Aesthetic ND:Yag LaserAcme Medical, Inc.1999755
K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc.2002739
K993671Candela Sclero Long Pulse Dye LaserCandela Corp.2000700
K023881Profile 1064 Laser SystemSciton, Inc2003227
K063828Diomed Delta 25Diomed, Ltd.20075
K052129Lumenis 1000 Integrated Slit LampLumenis, Inc.20055
K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical20020

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, K991234 (Acme Medical, Inc., 1999) has gone furthest, with 755 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?

532nm Wavelength: General Surgery: Coagulation, hemostasis, vaporization, excision, and incision of tissue. Photocoagulation of Vessels/Veins up to 1.5 mm Endoscopic & Laparoscopic: Excising, Coagulation or Vaporization of tissue during Endoscopic or Laparoscopic procedures, Cholecystectomy and Appendectomy. Gynecology: Ablation or lysis of intra-abdominal tissues via laparotomy or laparoscope. Ablation of endometrial implants, lysis of adhesions…

Read the full statement (694 words)

532nm Wavelength:

General Surgery:

Coagulation, hemostasis, vaporization, excision, and incision of tissue. Photocoagulation of Vessels/Veins up to 1.5 mm

Endoscopic & Laparoscopic:

Excising, Coagulation or Vaporization of tissue during Endoscopic or Laparoscopic procedures, Cholecystectomy and Appendectomy.

Gynecology:

Ablation or lysis of intra-abdominal tissues via laparotomy or laparoscope. Ablation of endometrial implants, lysis of adhesions, ablation of the uterosacral ligaments, cutting/coagulating, treatment of uterine polyps and fibroids, salpingo-ophorolysis, and transection of uterine septa.

Laryngology:

Photocoagulation or Vaporization of soft or fibrous tissue such as; hereditary hemorrhagic telangiectasia (vascular lesions), pigmented structures that are highly vascular, and tonsillectomy.

Otology:

For; stapedotomy, stapedectomy, tympanoplasty with fascia graft, myringotomies, control of bleeding, removal of osseous disease of the external canal, removal of acoustic neuromas, lysis of adhesions and soft tissue adhesion, in both micro- and macro- otologic procedures.

Rhinology:

For; control of epistaxis, turbinate reduction (excludes bone), treatment of endonasal polyps, hereditary hemorrhagic telangiectasia, synechia, hemangiomas, telangiectasia, vaporize of maxillary sinus cysts and polyps, treatment of papillomas and granulomas, endonasal dacryocystorhinostomy, treatment of lesions within the nose and sinus, creation of nasoantral window and coagulation of vessels or veins up to 1.5 mm in diameter.

Urology:

Coagulation of veins or vessels up to 1.5 mm in diameter, management of condyloma acuminata, carcinoma in situ, small papillary bladder tumors, port wine stains, hemangioma of the external genitalia or bladder and urethral recanalization.

Neurosurgery:

For; dorsal root entry zone lesions, spinal intramedullary tumor, medulloblastomas, acoustic neuromas, intracranial meningiomas, ventricular ependymomas, choroid plexus, carcinomas, hemangioblastomas, ependymoma extending into the brain stem, and intra- / extra- axial spinal cord tumors.

Ophthalmology:

For; posterior and anterior treatment procedures including; diabetic retinopathy, retinal detachments, ablate tissues of the iris or trabeculum, peripheral iridectomy and iridotomy, trabeculoplasty, and senile macular degeneration. Other conditions of the retina in which the laser is deemed useful involving endophotocoagulation. Extraorbital procedures such as; coagulation of vessels or veins up to 1.5 mm in diameter, extra orbital pigmented or venous lesions; port wine hemangiomas or telangiectasia. Treatment for chronic dacryocystitis.

Dermatology:

For; treating vascular lesions, dermatologic lesions, and/or cutaneous lesions such as; facial or extremities telangiectasias, venous anomalies, leg veins up to 1.5 mm in diameter, and port wine stains.

1064nm Wavelength:

General Surgery:

For; incision or excision of all soft body tissues including; skin, subcutaneous and breast tissue, striated and smooth muscle, tendon and fascia, cartilage, mucous membrane, lymphatic tissue, internal organs and glands of the gastrointestinal, genitourinary, pulmonary, endocrine and exocrine systems, as well as cancers of theses systems. Treatment of larger and deeper vessels/veins up to 3.0 mm in diameter, 4.0 to 7.0 mm in depth.

ENT, Head & Neck:

For; incision or excision of all soft body tissues including; skin, subcutaneous tissue, striated and smooth muscle, tendon and fascia, cartilage, mucous membrane, lymphatic tissue, organs and glands of the ENT system and access via endoscope, microscope or direct visualization.

Gastroenterology:

For; esophageal neoplastic obstructions such as; squamous cell carcinoma, and adenocarcinoma, upper and lower GI bleeding such as; varices, esophagitis, esophageal ulcer, Mallory-Weiss tear, gastric ulcer, stomach ulcer, duodenal ulcer, non-bleeding ulcer, gastric erosions and hereditary hemorrhagic telangiectasia. Papilliation of unresectable mucosal-based cancers, coagulation of arteriovenous malformations, ablation of; adenomatous polyps, benign and malignant neoplasm, angiodysplasia, polyps, ulcers, colitis and hemorrhoids. Recanalization of obstructing lesions throughout the gastrointestinal tract, and endoscopic treatment of early oesophageal or gastric cancer.

Gynecology:

For; endometrial ablation, treatment of menorrhagia, treatment of endometrotic implants, lysis of adhesions, treatment of cervical, vaginal, or vulvar dysplasia, and treatment of cervical, vaginal, or vulvar condyloma.

Neurology:

For; treatment of arterio-venous malformations, and vascular intracranial tumors like meningiomas and metastatic spinal tumors.

Pulmonary:

For; treatment of benign and malignant tracheobronchial lesions in the pulmonary airway including; squamous cell carcinoma, papillomas, adenocarcinoma, granulomas, and tracheal stenosis.

Urology:

Treatment of superficial and invasive bladder carcinoma, urethral and ureteral strictures, benign or malignant lesions of the external genitalia, urethra and anus (condyloma acuminata), bladder neck contracture, and diverticulum.

Dermatology:

Photocoagulation of vascular lesions for the reduction of lesion size. Treatment of vascular lesions such as; port wine stains (PWS), hemangiomas, angiomas, and venous anomilies. Incision/Excision of soft body tissues.

Otolaryngology:

Bronchoscopy procedures such as; photocoagulation of endobronchial tumors.

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

Cite this page

510(k) Report. “K981952: Combination ND:Yag and Frequency Doubled Solid State Green Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K981952

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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