Contact Nd:YAG Laser for Treatment of Menorrhagia

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K872253 ↗

FDA Product Code

HHR

Device Class

Class II

Regulation

21 CFR Part 884.4550

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from Surgical Laser Technologies, Inc. →

• What is the Contact Nd:YAG Laser used for?

  The Contact Nd:YAG Laser is a surgical device specifically designed for the treatment of menorrhagia (heavy menstrual bleeding) in gynecological procedures. It is a Class 2 laser device manufactured by Surgical Laser Technologies, Inc.

• What are the regulatory approvals for this device?

  The device received FDA 510(k) clearance with K number K872253 on October 6, 1987. It is regulated under product code HHR and is intended for use in obstetrics and gynecology settings.

• How is the Contact Nd:YAG Laser supplied and stored?

  The device is supplied as a surgical laser system for gynecological procedures. Specific storage requirements are not detailed in the provided information, but as a Class 2 medical device, it should be stored according to the manufacturer's instructions to maintain its functionality and safety.

• Is the Contact Nd:YAG Laser reusable or single-use?

  The device information does not specify whether the Contact Nd:YAG Laser is designed for single-use or multiple uses. As a surgical laser system, it may have components that are reusable while others are single-use, depending on the specific design and manufacturer's recommendations.