# K992687: Millenium Microkeratome, Model Imd-001

- Pathway: 510(k) (Traditional)
- Applicant: Industrial & Medical Design, Inc.
- Decided: Sep 24, 1999 after 45 days
- Product code: HMY (Keratome, Battery-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: 3 generations back to K935342 (1994). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980924: Plancon Microlamellar Keratome Evolution, Plancon Instruments (1998) Summary page 1.
- K970377: Plancon Microlamellar Keratome (Single Piece Keratome Head with Accessories), Plancon Instruments (1997) Summary page 1.

## Indications for use
Millenium Microkeratome is indicated for use in refractive surgery, or other treatment requiring initial lamellar resection of the cornea, circular and predetermined diameter and thickness.

Source page: https://510kreport.com/device/K992687
Methodology: https://510kreport.com/methodology