# K981103: Turbosonics Limited Reuse Ultrasonic Tip

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Laboratories
- Decided: Jun 23, 1998 after 89 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- 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 K851210 (1985). 8 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K911808: Gemini Ophthalmic Surgery System, Alcon Laboratories (1991) Summary page 2.
- K851210: United Sonics Phaco Module, DF-35, United Sonics, Inc. (1985) Summary page 2.
- K902876: Phacotron Systems Plus Iii Phacoemulsifier Aspi., Intraoptics Surgical, Inc. (1990) Summary page 2.
- K915456: Phaco 3000 Linear, Innovative Medical Systems, Inc. (1992) Summary page 2.
- K915457: Phaco 20/20 System I, Innovative Medical Systems, Inc. (1992) Summary page 2.
- K921460: Storz Premiere/Premiere Microvit Microsurg Systems, Storz Instrument Co. (1992) Summary page 2.
- K921758: Storz Protege Opthalmic Microsurgical System, Storz Instrument Co. (1992) Summary page 2.
- K925631: Phacotron Gold Multifunction Ultrasonic Handpiece, Chiron Intraoptics (1993) Summary page 2.

## Most influential descendants
- K030179: Medisiss Phacoemulsification Tips/Needles (2003), 4 descendants of its own
- K041841: Pachycam (2005), 3 descendants of its own
- K073508: Parkone (2008), 1 descendant of its own
- K202989: Myopia Master (2021), 0 descendants of its own
- K113066: Corvis ST (2012), 0 descendants of its own

## Indications for use
The intended use of this device is to assist in the automated phacoemulsification of a natural crystalline lens.

Source page: https://510kreport.com/device/K981103
Methodology: https://510kreport.com/methodology