# K032910: Carriazo Pendular

- Pathway: 510(k) (Traditional)
- Applicant: Schwind Eye-Tech-Solutions GmbH & Co. KG
- Decided: Aug 30, 2004 after 343 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: 4 generations back to K935342 (1994). 14 ancestors in all.
58 later devices descend from it; 3 cite it directly.
0 of 73 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981741: Carriazo Barraquer Microkeratome, Moria, Inc. (1998) Summary page 1.
- K972808: Hansatome Microkeratome, Chiron Vision Corp. (1997) Summary page 1.
- K980924: Plancon Microlamellar Keratome Evolution, Plancon Instruments (1998) Summary page 1.
- K021640: Hansatome Excellus Microkeratome, Bausch & Lomb, Inc. (2002) Summary page 1.
- K990227: Ultrashaper Keratome, Lasersight Technologies, Inc. (2000) Summary page 1.
- K014000: Vistitome 20-10 Microkeratome, Biovision AG (2002) Summary page 1.

## Most influential descendants
- 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
- K101626: Lensx Laser System (2010), 30 descendants of its own

## Indications for use
The Carriazo Pendular Microkeratome is indicated for shaving the cornea prior to lamellar (partial thickness) transplant or to create a flap in the cornea.

Source page: https://510kreport.com/device/K032910
Methodology: https://510kreport.com/methodology