# K973294: Innovatome Microkeratome

- Pathway: 510(k) (Traditional)
- Applicant: Innovative Optics, Inc.
- Decided: Oct 3, 1997 after 31 days
- Product code: HNO (Keratome, Ac-Powered)
- Device class: 1
- Regulation: 21 CFR 886.4370
- 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 K935342 (1994). 3 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960395: Plancon Mircolamellar Keratome, Plancon Instruments (1996) Summary page 3.
- K970377: Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories), Plancon Instruments (1997) Summary page 4.

## Cited in the summary but kept off the family tree
- K940155: Enline Endoscopic Surgical Instruments, Surgigus Instruments, Inc. (1994). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K990900: Microkeratome, Model MK-2000 (1999), 2 descendants of its own
- K983317: Barron Microkeratome System, Model B2000 (1998), 1 descendant of its own
- K032297: Disposable N-PE Mickrokeratome Blades (2003), 0 descendants of its own
- K022205: Disposable N-PE Microkeratome Blades (2002), 0 descendants of its own
- K991124: Visijet Hydrokeratome, Model 50 (2000), 0 descendants of its own

## Indications for use
The INNOVATOME" microkeratome system 1s indicated for the resection of a circulal anterior lamellar flap.

Source page: https://510kreport.com/device/K973294
Methodology: https://510kreport.com/methodology