# K022181: Novus Varia Ophthalmic Laser and Delivery Devices with Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Oct 1, 2002 after 90 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 K894841 (1989). 11 ancestors in all.
65 later devices descend from it; 14 cite it directly.
0 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932468: Novus Multiwavelength, Coherent Medical Group (1993) Summary page 1.
- K960971: Oculight GL, Iriderm Div. (1996) Summary page 1.
- K913127: Coherent Novus 3000 Argon Photocoagulator, Coherent Medical Group (1991) Summary page 1.
- K837235: Model 920 Argon Laser System, Coherent Radiation Laboratories (1983) Summary page 1.
- K000498: Coherent Laserlink Z-1000 Slit Lamp Laser Delivery Adapter, Lumenis, Inc. (2000) Summary page 1.
- K991258: Novus Verdi Delivery Systems, Lumenis, Inc. (1999) Summary page 1.
- K885196: Laser Indirect Ophthalmoscope (Lio), Coherent Medical Group (1989) Summary page 1.

## Most influential descendants
- K043486: Pascal Photocoagulator, Product-Pascal-01 (2005), 29 descendants of its own
- K091666: Pascal Photocoagulator, Pascal-US (2009), 23 descendants of its own
- K092621: Pascal Streamline Photocoagulator (2009), 22 descendants of its own
- K081744: Pascal Synthesis Delivery System (2008), 17 descendants of its own
- K100019: Pascal Streamline Photocoagulator (2010), 16 descendants of its own

## Indications for use
The Novus Varia Ophthalmic Laser and Delivery Devices is intended for use in the treatment of ocular pathology. The Lumenis Varia is indicated for use in photocoagulation of both anterior and posterior segments including: Retinal photocoagulation, panretinal photocoagulation and intravitreal endophotocoagulation of vascular and structural abnormalities of the retina and choroid including: - proliferative and nonproliferative diabetic retinopathy; - choroidal neovascularization; - branch retinal vein occlusion; - age-related macular degeneration - retinal tears and detachments - retinopathy of prematurity Iridotomy, iridectomy and trabeculoplasty in angle closure glaucoma and open angle glaucoma Laser Indirect Ophthalmoscope The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments: diabetic retinopathy (panretinal photocoagulation); retinopexy; segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; and, pediatric retinal repairs (under general anesthesia) Endophotocoagulation The Acculite Endoprobe is indicated for use in the following ophthalmic applications: photocoagulation of the anterior and posterior segment, including: anterior segment treatment in the surgical management of glaucoma; endophotocoagulation in vitreoretinal surgery, including panretinal photocoagulation, retinopexy, and treatment of neovascularization.

Source page: https://510kreport.com/device/K022181
Methodology: https://510kreport.com/methodology