# K980389: Megabeam Reusable Fiber Optic Handpiece and Needles

- Pathway: 510(k) (Traditional)
- Applicant: Ceram Optec, Inc.
- Decided: Jul 29, 1998 after 177 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: 2 generations back to K904627 (1991). 20 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923953: Megabeam, Ceram Optec, Inc. (1992) Summary page 1.
- K946336: Megabeam Fiber Optic Delivery System, Hogan & Hartson (1995) Summary page 1.
- K943445: Megabeam Fiber Optic Delivery System, Ceram Optec, Inc. (1994) Summary page 1.
- K960032: Coherent Versapulse Aesthetic Surgical Lasers, Coherent Medical Group (1996) Summary page 1.
- (no number) TTI Medical’s Optic Handpiece: named in the summary without a submission number

## Most influential descendants
- K061025: Accutech Endolite Probe (2006), 1 descendant of its own
- K090281: Accutech Family of Powerflex Laser Delivery Devices (2009), 0 descendants of its own
- K060905: Iridex Otoprobe Long and Short Angles, P/N 14310-1 and 14320-1 (2006), 0 descendants of its own

## Indications for use
Intended to be used as a fiber optic delivery system handpiece with the capability to be reused with a disposable optical fiber.

Source page: https://510kreport.com/device/K980389
Methodology: https://510kreport.com/methodology