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510(k) Data Aggregation
(62 days)
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.
Lumenis, Inc.'s Novus® 3000 Laser System with the Delivery Devices is an air cooled, diode-pumped, solid state, Nd: YAG Laser System, which produces a wavelength of 532 um of laser light with a treatment beam output ranging from 50 mw to 3.0 W. The main parts of the Novus® 3000 system include the laser console, a footswitch, a remote control and assorted laser accessories.
This 510(k) summary for the Lumenis Novus® 3000 Laser System and Delivery Devices does not include any performance data or a study to demonstrate that the device meets specific acceptance criteria.
The document explicitly states:
"No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation). No data was submitted for section 807.92 6[(b)(1)(2)(3c)]."
Therefore, I cannot provide the requested information. The submission relies on demonstrating substantial equivalence to predicate devices based on similarities in intended use, indications for use, and technological characteristics, rather than on new performance data for this specific device.
If this were a submission that included a performance study, the requested information would typically be provided as follows:
Hypothetical Example if performance data were submitted:
Here's how the information would be presented if a study was conducted and acceptance criteria were defined, based on a typical medical device submission structure:
1. Table of Acceptance Criteria and Reported Device Performance (Hypothetical Example)
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Laser Output Power Accuracy | Within ±10% of set value | ±5% (e.g., for 50 mW to 3.0 W range) |
| Beam Spot Size Accuracy | Within ±15% of nominal size | ±10% (e.g., for various delivery devices) |
| Pulse Duration Accuracy | Within ±5% of set value | ±2% (e.g., for 10 ms to 1000 ms range) |
| Aiming Beam Co-axiality | Within 0.5 mm relative to treatment beam |
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