ML7040 (Plus 20) ML7040 (+20)

• FDA 510(k) K002515 decided 22 Feb 2001 Active
• FDA GUDID UDI-DI 00850724001247 listed 14 Aug 2020 Listed

1. 22 Feb 2001 Cleared FDA 510(k) K002515
2. 14 Aug 2020 Listed FDA GUDID 00850724001247

Trade name

ML7040 (Plus 20)

Generic name

Keratome blade, single-use

Model / Ref / Catalog

ML7040 (+20)

Primary DI / UDI-DI

00850724001247

510(k) Number

K002515 ↗

FDA product code

HNO

GMDN term

Keratome blade, single-use

Device class

Class I

Regulation number

886.4370

GUDID distribution status

In Commercial Distribution

Sterilisation method

Ethylene Oxide

Category: Keratome blade, single-use

Other devices filed under FDA product code HNO (Keratome, Ac-Powered).

• ULTRAEDGE KERATOME BLADE, MODEL 374803 - ACS by Lasersight Technologies, Inc.
• Treatment Pack (Size M) 1014 by Carl Zeiss Meditec AG
• MICROKERATOME, MODEL MK-2000 by Nidek, Inc.
• AUTOMATED DISPOSABLE KERATOME (ADK) by Lasersight Technologies, Inc.
• MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME by Ciba Vision Corporation
• MICROKERATOME OR THE MATE by Howard Instruments, Inc.
• Treatment Packs (Size M) 1462-333 by Carl Zeiss Meditec AG
• BLADEWORKS MICROKERATOME BLADE, MODEL 7061 by Blade Works, Inc.
• INNOVATOME MICROKERATOME by Innovative Optics, Inc.
• MODIFICATION TO VISITOME 20-10 MICROKERATOME by Biovision, Inc.

• ML7003

  Class I

  FDA 510(k) K962661 Active Cleared 9 Dec 1996 GUDID on market

• ML7040 (Minus 20) ML7040 (-20)

  Class I

  FDA 510(k) K002515 Active Cleared 22 Feb 2001 GUDID on market

• ML7040 (Plano) ML7040 (0)

  Class I

  FDA 510(k) K002515 Active Cleared 22 Feb 2001 GUDID on market

• Clb®

  Class IIa

  CE/MDD GUDID on market

See all devices from Med Logics Inc →