# K990227: Ultrashaper Keratome

- Pathway: 510(k) (Traditional)
- Applicant: Lasersight Technologies, Inc.
- Decided: Jan 31, 2000 after 371 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 K860001 (1986). 3 ancestors in all.
59 later devices descend from it; 1 cites it directly.
0 of 63 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K941550: Automatic Corneal Shaper Surgical Instrument, Chiron Vision Corp. (1994) Summary page 1.
- K860001: Barraquer-Krumeich Refractive Set, American Medical Optics (1986) Summary page 1.
- K903912: Keratome, Micro Precision Instrument Co. (1990) Summary page 1.

## Most influential descendants
- 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
- K092647: Lensx 550 Laser System (2009), 31 descendants of its own

## Indications for use
The UltraShaper™ System is an AC-powered device that is intended to shave a partial lamella section of the cornea.

Source page: https://510kreport.com/device/K990227
Methodology: https://510kreport.com/methodology