# K052526: Novus 3000 Laser System and Delivery Devices

- Pathway: 510(k) (Traditional)
- Applicant: Lumenis, Inc.
- Decided: Nov 15, 2005 after 62 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: 4 generations back to K894841 (1989). 37 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 42 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.
- K032357: Novus TTX Laser and Delivery Devices with Accessories, Lumenis, Inc. (2003) Summary page 1.
- K052129: Lumenis 1000 Integrated Slit Lamp, Lumenis, Inc. (2005) Summary page 1.
- K931784: HGM Illuminating Imaging Endocular Probe, Hgm, Inc. (1994) Summary page 1.
- K931072: HGM Illuminating/Aspirating Endoocular Probe, Hgm, Inc. (1994) Summary page 1.

## Cited in the summary but kept off the family tree
- K022357: Transend 300 ES Guidewire, Model 46-814 & Transend 300 Floppy Guidewire, Model 46-815, Boston Scientific, Target (2002). Our reading of the summary gave K022357, FDA’s number for Transend 300 ES Guidewire, Model 46-814 & Transend 300… (Boston Scientific, Target). Its FDA name has none of the distinctive words the summary uses for the device it names, “Illuminating EndoOcular Probe”. Kept off the family tree. Summary page 1.

## Most influential descendants
- 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 Novus 3000 Laser System is intended for use in the treatment of ocular pathology. The Novus 3000 Laser System 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, 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 the delivery of laser energy in eyes with retinal pathology. The Laser Indirect Ophthalmoscope is indicated for use in the following ophthalmic treatments and conditions: diabetic retinopathy (panretinal photocoagulation); peripheral neovascularization, retinal breaks, detachments, and tears, lattice degeneration, pneumatic retinopexy reattachment procedures, segmental peripheral photocoagulation; segmental photocoagulation; cloudy vitreous cavities; pediatric retinal repairs (under general anesthesia), delivery of laser energy through small pupils or to eyes with focal lens opacities. Endophotocoagulation When used with a Novus 3000 Laser System, the Acculite EndoOcular Probes (Acculite EndoOcular Probe, Acculite Aspirating EndoOcular Probe, and Acculite Illuminating EndoOcular Probe) are intended 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. The laser delivery function of the Acculite Acculite EndoOcular Probes (Acculite EndoOcular Probe, Acculite Aspirating EndoOcular Probe and Acculite Illuminating EndoOcular Probe) is indicated for use in ocular surgery to deliver laser energy to the treatment area selected by the surgeon. The aspiration function of the Acculite Aspirating EndoOcular Probe is indicated for use when unwanted fluid is present in the eye during ocular surgery, causing refraction or scattering of the laser beam from the intended treatment site. The illumination function of the Acculite Illuminating EndoOcular Probe is indicated for use during ocular surgery to illuminate the interior of the eye.

Source page: https://510kreport.com/device/K052526
Methodology: https://510kreport.com/methodology