# K981063: Automated Corneal Trephine

- Pathway: 510(k) (Traditional)
- Applicant: Laser Center Dev. Corp.
- Decided: Jun 23, 1998 after 92 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: 1 generation back to K864520 (1987). 1 ancestor in all.
61 later devices descend from it; 2 cite it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864520: Barron Rotary Blade Trephine Using Hessburg-Barron, Precision Instruments, Inc. (1987) 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
Lamellar keratoplasty Penetrating Keratoplasty

Source page: https://510kreport.com/device/K981063
Methodology: https://510kreport.com/methodology