# K960395: Plancon Mircolamellar Keratome

- Pathway: 510(k) (Traditional)
- Applicant: Plancon Instruments
- Decided: Apr 26, 1996 after 88 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
No predicates in its family tree.
77 later devices descend from it; 3 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K970377: Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories) (1997), 76 descendants of its own
- K980924: Plancon Microlamellar Keratome Evolution (1998), 66 descendants of its own
- K981741: Carriazo Barraquer Microkeratome (1998), 63 descendants of its own
- K032910: Carriazo Pendular (2004), 58 descendants of its own
- K073404: Ifs Laser System (2008), 56 descendants of its own

## Indications for use
To perform micro lamellar keratoplasty for the correction of myopia or hyperopia

Source page: https://510kreport.com/device/K960395
Methodology: https://510kreport.com/methodology