510(k) Report

510(k) · Cleared

Cleared

Endo-Lse CD-100 CO2 Laser for Gynecology

K853876510(k) TraditionalCleared Feb 21, 1986157-day reviewClass II21 CFR 884.4550

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

Endo Lase, Inc. · HHR Laser, Surgical, Gynecologic

Cleared on Feb 21, 1986 after a 157-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 21, 1986
Review
157 days
Class
Class II
Product code
HHR
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K853876Source: 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.

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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 HHR devices

HHR Laser, Surgical, Gynecologic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · HHR

FDA has decided no HHR device since 2007.

Median 510(k) review, days · HHR

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

Recalls per year · HHR

No recall names HHR since 2007.

Adverse event reports per year · HHR

2in 2015

2007: 12011: 12015: 2
2007high 2 (2015) · low 0 (2008)2025

MAUDE reports naming product code HHR, 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—01
20080—00
20090—00
20100—00
20110—01
20120—00
20130—00
20140—00
20150—02
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Endo Lase, Inc.

24 FDA decisions under this applicant name. See the company

  • K853900Endo-Lase CD40 for NeurosurgeryEndo Lase, Inc. · 1986
  • K853878Endo-Lase CD-100 CO2 Laser for NeurosurgeryEndo Lase, Inc. · 1986
  • K853903Endo-Lase CD40 CO2 for GynecologyEndo Lase, Inc. · 1986
  • K855093Medilas 2 ND:Yag Laser Surgery SystemEndo Lase, Inc. · 1986
  • K853877Endo-Lase CD-100 CO2 Laser for DermatologyEndo Lase, Inc. · 1986

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  • K875314GL-35 Colposcopic Laser SystemLaser Engineering, Inc. · 1988
  • K874615Laser Cannister FilterMedical Marketing, Inc. · 1988
  • K880591Laseguide 600A, 600B, 400A, 400B for OB-Gyn UseLaser Peripherals, LLC · 1988

https://510kreport.com/device/K853876 · printed Nov 6, 2026

Cite this page

510(k) Report. “K853876: Endo-Lse CD-100 CO2 Laser for Gynecology.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K853876

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