# K014048: Clinicon Universal Waveguide Handpiece and Fiber Tips

- Pathway: 510(k) (Traditional)
- Applicant: Clinicon Corp.
- Decided: Feb 11, 2002 after 66 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K953074 (1995). 5 ancestors in all.
15 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903079: Endoguide (R), Microguide (TM), Flexiguide (TM), Luxar Corp. (1990) Summary page 1.
- K992472: Sureguide CO2 Laser Beam Delivery System, Clinicon Corp. (1999) Summary page 1.

## Most influential descendants
- K050541: Omniguide Beampath CO2 Mark I Laser Beam Delivery (2005), 14 descendants of its own
- K070157: Omniguide Beam Path CO2 Mark Iii Waveguide Fiber (2007), 8 descendants of its own
- K073313: Mark Iii Waveguide Fiber with Low Profile Tip (2008), 5 descendants of its own
- K093451: Omniguide Beampath CO2 Mark Iii Waveguide Fiber with Low Profile/Low Loss Tip (2009), 4 descendants of its own
- K140378: Flexguide Ultra Beampath Robotic Fiber Conduit (2014), 2 descendants of its own

## Indications for use
The Clinicon UHP/disposable tip is/are indicated for use in general and plastic surgery, neurosurgery, ophthalmology, oral surgery, oto-rhino-laryngology, podiatry, gynecology, and urology procedures for incision, excision, vaporization, ablation, coagulation, cauterization of soft tissue. The Clinicon UHP/disposable tip indications are dependent upon the cleared indications for use of the laser system and laser system accessories to which it is attached.

Source page: https://510kreport.com/device/K014048
Methodology: https://510kreport.com/methodology