# K980924: Plancon Microlamellar Keratome Evolution

- Pathway: 510(k) (Traditional)
- Applicant: Plancon Instruments
- Decided: Apr 15, 1998 after 35 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.
66 later devices descend from it; 4 cite it directly.
0 of 70 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 2.
- K970377: Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories), Plancon Instruments (1997) Summary page 2.

## Most influential descendants
- 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
- K082947: Lensx 550 Laser System (2009), 51 descendants of its own
- K094052: Lensx 550 Laser System. Model 550 (2010), 47 descendants of its own

## Indications for use
This device is intended for use in refractive surgery, to perform microlamellar keratoplasty or keratomileusis in-situ for the correction of myopia and hyperopla

Source page: https://510kreport.com/device/K980924
Methodology: https://510kreport.com/methodology