# K013151: Asmotom Automated Trephine System

- Pathway: 510(k) (Traditional)
- Applicant: Bkg Opthalmics USA, Inc.
- Decided: Dec 14, 2001 after 85 days
- Product code: HRG (Engine, Trephine, Accessories, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4070
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K954058 (1995). 2 ancestors in all.
61 later devices descend from it; 2 cite it directly.
0 of 64 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980675: Summit Krumeich-Barraquer Microkeratome, Summit Technology, Inc. (1998) Summary page 1.

## Most influential descendants
- K041893: Intralase FS Laser (2005), 60 descendants of its own
- K060372: Intralase FS Laser, Intralase FS30 Laser, Models 1, 2, 3 (2006), 58 descendants of its own
- K063682: Intralase Fusion Laser (2007), 57 descendants of its own
- K073404: Ifs Laser System (2008), 56 descendants of its own
- K082947: Lensx 550 Laser System (2009), 51 descendants of its own

## Indications for use
The ASMOTOM Automated Trephine System is intended to perform penetrating cuts of the central portion of the cornea. The purpose of this device is to produce cuts necessary for the corneal transplantation.

Source page: https://510kreport.com/device/K013151
Methodology: https://510kreport.com/methodology