# K030033: Lumenis Family of Disposable Contact Tip Delivery Devices

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Ltd.
- Decided: Jul 21, 2003 after 199 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: 8 generations back to K936109 (1994). 75 ancestors in all.
No later device cites it as a predicate yet.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories, Lumenis, Inc. (2002) Summary page 2.
- K894211: Sharplan Series 2900 Synthetic Contact Tips, Sharplan Lasers, Inc. (1989) Summary page 1.
- K010041: SLT Diffuser Fiber, Surgical Laser Technologies, Inc. (2001) Summary page 2.
- K980156: SLT Select Fiber Delivery System and Contact Tips, Surgical Laser Technologies, Inc. (1998) Summary page 1.
- K882212: SLT Contact Laser System, Surgical Laser Technologies, Inc. (1988) Summary page 1.
- K872254: SLT Contact ND:Yag Laser for Intra-Abdom.&Genital, Surgical Laser Technologies, Inc. (1987) Summary page 1.
- K872253: Contact ND:Yag Laser for Treatment of Menorrhagia, Surgical Laser Technologies, Inc. (1987) Summary page 1.
- K973618: Somnoplasty System, Somnus Medical Technologies, Inc. (1997) Summary page 1.
- K021364: Modification to Entec Plasma Wands, Arthrocare Corp. (2002) Summary page 2.

## Indications for use
The Lumenis Family of Disposable Contact Tip Delivery Devices for CO2 Lasers is indicated for use in surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue using laser-generated thermal energy in medical specialties, including aesthetic (dermatology and .plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery, for the indications for use that the compatible laser system to which attached has been cleared.

Source page: https://510kreport.com/device/K030033
Methodology: https://510kreport.com/methodology