# K052129: Lumenis 1000 Integrated Slit Lamp

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Aug 30, 2005 after 25 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 K894841 (1989). 15 ancestors in all.
5 later devices descend from it; 1 cites 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)
- K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories, Lumenis, Inc. (2002) Summary page 1.
- K022327: Novus Spectra, Lumenis, Inc. (2002) Summary page 1.
- K000498: Coherent Laserlink Z-1000 Slit Lamp Laser Delivery Adapter, Lumenis, Inc. (2000) Summary page 1.
- K990174: Atlas-Elite,Model E-80,Corium 200,Corium 400, Model E-90, Elite, Model E-80-II, Elite Ultra, Model E-80-IV, Fisma, Inc. (1999) Summary page 1.
- K981952: Combination ND:Yag and Frequency Doubled Solid State Green Laser, Instruments For Medicine and Diagnostics (1998) Summary page 1.

## Most influential descendants
- K052526: Novus 3000 Laser System and Delivery Devices (2005), 4 descendants of its own
- K062336: Optimedica Laser Indirect Ophthalmoscope (2006), 1 descendant of its own
- K061025: Accutech Endolite Probe (2006), 1 descendant of its own
- K123056: Pascal Laser Indirect Ophthalmoscope (2012), 0 descendants of its own
- K090281: Accutech Family of Powerflex Laser Delivery Devices (2009), 0 descendants of its own

## Indications for use
The Lumenis 1000 Integrated Slit Lamp laser delivery system is indicated for a variety of ophthalmic diagnostic and treatment uses including, but not limited to, the indications specified in the compatible laser's Operator Manuals. The Lumenis 1000 Integrated Slit Lamp may be used in the medical specialties or procedures that have been given market clearance by the Food and Drug Administration through the compatible laser systems. The Lumenis 1000 Integrated Slit Lamp is compatible with Lumenis lasers only.

Source page: https://510kreport.com/device/K052129
Methodology: https://510kreport.com/methodology