# K970377: Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories)

- Pathway: 510(k) (Traditional)
- Applicant: Plancon Instruments
- Decided: Mar 31, 1997 after 56 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: 1 generation back to K935342 (1994). 2 ancestors in all.
76 later devices descend from it; 7 cite it directly.
0 of 79 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 1.
- K935342: SCMD Keratome, S.C.M.D. Keratomes of Arizona (1994) Summary page 1.
- (no number) EYE TECHNOLOGY Microlamellar Keratome: named in the summary without a submission number

## Most influential descendants
- 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
- K082947: Lensx 550 Laser System (2009), 51 descendants of its own

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

Source page: https://510kreport.com/device/K970377
Methodology: https://510kreport.com/methodology