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Surgical Carbon Dioxide Sys. Model 10-C Ob-Gyn Use

by Directed Energy, Inc. 510(k)

Active United States

510(k) K862861

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK862861 Date27 Oct 1986ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HHR
Device Class
Class II
Regulation
21 CFR Part 884.4550
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Surgical Carbon Dioxide Laser (Product Code HHR), classified under the FDA’s Laser, Surgical, Gynecologic category. It emits carbon dioxide light energy to cut, destroy, or remove tissue, primarily intended for obstetrics and gynecology procedures. The system operates within the regulatory framework of Class II medical devices, requiring premarket notification (510(k)) clearance.

The Model 10-C is supplied as a reusable surgical laser system designed for use in obstetrics and gynecology settings. It requires proper training and adherence to sterile techniques, though specific sterility claims are not stated in the data. The device is authorized under FDA 510(k) clearance K862861, with no additional regulatory markings or MRI safety classifications provided. Storage and maintenance instructions are not detailed in the available specifications.

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