Colposcopes and Accessories

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K940094 ↗

FDA Product Code

HEX

Device Class

Class II

Regulation

21 CFR Part 884.1630

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

• LM 1000 Cryosurgical Accessories

  Class II

  FDA 510(k) K854767 Active Cleared 24 Jan 1986

• Lm- Lap 10 High Flow Insufflator

  Class II

  FDA 510(k) K914201 Active Cleared 9 Jan 1992

• Max-E-Vac

  Class II

  FDA 510(k) K920217 Active Cleared 23 Jul 1992

• Lm-100/200LOW Flow Insufflator

  Class II

  FDA 510(k) K912789 Active Cleared 20 Sep 1991

• Lm-1Z Zoom Scope

  Class II

  FDA 510(k) K902313 Active Cleared 4 Sep 1990

• LM-150HT Light Source

  Class III

  FDA 510(k) K911212 Active Cleared 23 May 1991

See all devices from Leisegang Medical, Inc. →

• What is the purpose of Leisegang colposcopes?

  Leisegang colposcopes are medical devices designed for detailed visualization of the cervix, vagina, vulva, and anogenital areas during gynecological examinations, providing magnified, non-contact viewing with a convergent optical beam path for fatigue-free work.

• What are the lighting specifications of Leisegang colposcopes?

  Leisegang colposcopes feature LED lighting with a color temperature of 5,700-6,000 Kelvin and provide lighting strength of 45,000-52,000 Lux at a working distance of 300mm, ensuring excellent contrast during examinations.

• What regulatory status do Leisegang colposcopes have?

  Leisegang colposcopes have FDA 510K clearance with product code HEX and are manufactured by Leisegang Medical, Inc., complying with medical and technical quality requirements, guidelines and regulations.

• What is the working distance of Leisegang colposcopes?

  Leisegang colposcopes have a working distance of 300mm, which allows for comfortable examination without the need for the clinician to be too close to the patient, reducing fatigue during extended procedures.