510(k) Report

510(k) · Cleared

Cleared

Minuteman CO2 Microsurg Laser Gen Surg

K843519510(k) TraditionalCleared Dec 7, 198493-day reviewClass I21 CFR 878.4820

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

American Surgical Laser, Inc. · GEY Motor, Surgical Instrument, Ac-Powered

Cleared on Dec 7, 1984 after a 93-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Dec 7, 1984
Review
93 days
Class
Class I
Product code
GEY
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K843519Source: FDA 510(k) database · 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), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

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.

How does its category compare?

All GEY devices

GEY Motor, Surgical Instrument, Ac-Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEY

FDA has decided no GEY device since 2007.

Median 510(k) review, days · GEY

Too few GEY 510(k)s in any year since 2007 to give a median.

Recalls per year · GEY

2in 2013

2008: 12009: 12012: 12013: 2
2007high 2 (2013) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GEY

965in 2025

2007: 192008: 92009: 42010: 42011: 112012: 142013: 9012014: 7382015: 2,0132016: 1,9432017: 2,1192018: 1,2882019: 1,1312020: 9522021: 1,1452022: 1,3602023: 1,4442024: 1,4472025: 965
2007high 2,119 (2017) · low 4 (2009)2025

MAUDE reports naming product code GEY, 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
20070—019
20080—19
20090—14
20100—04
20110—011
20120—114
20130—2901
20140—0738
20150—02,013
20160—01,943
20170—02,119
20180—01,288
20190—01,131
20200—0952
20210—01,145
20220—01,360
20230—01,444
20240—01,447
20250—0965
20260—0—

More from American Surgical Laser, Inc.

5 FDA decisions under this applicant name. See the company

  • K843515Minuteman CO2 Microsurgical Laser GynAmerican Surgical Laser, Inc. · 1985
  • K843517Minuteman CO2 Microsurg Laser Dermatol-American Surgical Laser, Inc. · 1984
  • K843518Minuteman C02 Microsurg Laser PodiatryAmerican Surgical Laser, Inc. · 1984
  • K843514Minuteman CO2 Microsurgical Laser OtoAmerican Surgical Laser, Inc. · 1984

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The GEY category page

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https://510kreport.com/device/K843519 · printed Nov 6, 2026

Cite this page

510(k) Report. “K843519: Minuteman CO2 Microsurg Laser Gen Surg.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K843519

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026