# K022723: Mastel 1 Folder Implantation System

- Pathway: 510(k) (Traditional)
- Applicant: Mastel Precision, Inc.
- Decided: Dec 26, 2002 after 132 days
- Product code: KYB (Lens, Guide, Intraocular)
- Device class: 1
- Regulation: 21 CFR 886.4300
- 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 K930320 (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)
- K961242: Amo Phacoflex II Intersection System, Allergan, Inc. (1996) Summary page 1.
- K001157: Monarch II Iol Delivery System, Alcon Research, Ltd. (2000)

## Indications for use
The Mastel 1 FolderTM Implantation System is intended to fold and assist in inserting the SENSARTM, model AR40e intraocular lens, ONLY into the capsular bag.

Source page: https://510kreport.com/device/K022723
Methodology: https://510kreport.com/methodology