# K993154: Laser Photolysis System, Pharo Ophthalmic Surgery System

- Pathway: 510(k) (Traditional)
- Applicant: A.R.C. Laser Corp.
- Decided: Jun 29, 2000 after 282 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K894278 (1989). 4 ancestors in all.
49 later devices descend from it; 2 cite it directly.
0 of 54 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952213: Alcon Series 20000 Legacy Phacoemulsifier, Alcon Laboratories (1995) Summary page 1.
- K894278: Storz Daisyplus Series Microsurgical Systems, Storz Instrument Co. (1989) Summary page 1.
- K921460: Storz Premiere/Premiere Microvit Microsurg Systems, Storz Instrument Co. (1992) Summary page 1.
- K946227: Storz Premiere (R) Microsurgical System, Storz Instrument Co. (1995) Summary page 1.
- (no number) Alcon Accuras: named in the summary without a submission number

## Most influential descendants
- K094052: Lensx 550 Laser System. Model 550 (2010), 47 descendants of its own
- K101626: Lensx Laser System (2010), 30 descendants of its own
- K113151: Ifs Laser System (2012), 19 descendants of its own
- K113479: Optimedica Catalys Precision Laser System (2011), 13 descendants of its own
- K120732: Lenssx Laser System (2012), 12 descendants of its own

## Recalls of this device
- Jun 6, 2003 · Not classified · Z-0981-03: Product may not have been properly sterilized.

## Indications for use
The Laser Photolysis System is indicated for use in phacofragmentation of the cataractous crystalline lens. The Pharo Ophthalmic Surgery System is indicated for use in phacofragmentation of the cataractous crystalline lens, and anterior and posterior ophthalmic surgery.

Source page: https://510kreport.com/device/K993154
Methodology: https://510kreport.com/methodology