510(k) · Cleared
ClearedCombination ND:Yag and Frequency Doubled Solid State Green Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- This deviceK981952 Combination ND:Yag and Frequency Doubled Solid State Green LaserInstruments For Medicine and Diagnostics · 1998
- Descendant · cites it directly · 755 of its ownK991234 The Acme Medical Aesthetic ND:Yag LaserAcme Medical, Inc. · 1999
- Descendant · cites it directly · 739 of its ownK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- Descendant · cites it directly · 700 of its ownK993671 Candela Sclero Long Pulse Dye LaserCandela Corp. · 2000
- Descendant · 2 generations on · 699 of its ownK013748 Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K981952 | Combination ND:Yag and Frequency Doubled Solid State Green Laser | Instruments For Medicine and Diagnostics | 1998 | — |
| +1 | K991234 | The Acme Medical Aesthetic ND:Yag Laser | Acme Medical, Inc. | 1999 | — |
| +1 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| +1 | K993671 | Candela Sclero Long Pulse Dye Laser | Candela Corp. | 2000 | — |
| +2 | K013748 | Candela Sclero Long Pulse Laser (Aka Vbeam) | Candela Corp. | 2002 | — |
| +2 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 6 | 0 |
| 2003 | 7 | 0 |
| 2004 | 8 | 0 |
| 2005 | 9 | 0 |
| 2006 | 9 | 0 |
| 2007 | 16 | 0 |
| 2008 | 28 | 0 |
| 2009 | 17 | 0 |
| 2010 | 19 | 0 |
| 2011 | 25 | 0 |
| 2012 | 23 | 0 |
| 2013 | 30 | 0 |
| 2014 | 32 | 0 |
| 2015 | 27 | 0 |
| 2016 | 40 | 0 |
| 2017 | 33 | 0 |
| 2018 | 34 | 0 |
| 2019 | 24 | 0 |
| 2020 | 42 | 0 |
| 2021 | 32 | 0 |
| 2022 | 55 | 0 |
| 2023 | 43 | 0 |
| 2024 | 71 | 0 |
| 2025 | 84 | 0 |
| 2026 | 47 | 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? (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 |
|---|---|---|---|
| * | — | 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 7637 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K991234 | The Acme Medical Aesthetic ND:Yag Laser | 1999 | 755 |
| K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and… | 2002 | 739 |
| K993671 | Candela Sclero Long Pulse Dye Laser | 2000 | 700 |
| K023881 | Profile 1064 Laser System | 2003 | 227 |
| K063828 | Diomed Delta 25 | 2007 | 5 |
| K052129 | Lumenis 1000 Integrated Slit Lamp | 2005 | 5 |
| K021650 | Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser | 2002 | 0 |
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 devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
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.
https://510kreport.com/device/K981952 · printed Nov 4, 2026
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