NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES

K052526 · Lumenis, Inc. · GEX · Nov 15, 2005 · General, Plastic Surgery

Device Facts

Record IDK052526
Device NameNOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES
ApplicantLumenis, Inc.
Product CodeGEX · General, Plastic Surgery
Decision DateNov 15, 2005
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4810
Device ClassClass 2
AttributesTherapeutic, Pediatric

Intended 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. 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. 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.

Device Story

Air-cooled, diode-pumped, solid-state Nd:YAG laser system; produces 532 nm wavelength light; output 50 mW to 3.0 W. System includes laser console, footswitch, remote control, and delivery accessories (slit lamp adapters, indirect ophthalmoscopes, endophotocoagulation probes). Operated by ophthalmologists in clinical or surgical settings. Surgeon selects treatment area; laser energy delivered via foot switch control. Aspiration probe removes fluid interfering with beam path; illumination probe provides internal eye visibility. Output affects tissue via photocoagulation to treat vascular/structural abnormalities. Benefits include precise retinal/anterior segment repair and management of ocular pathologies.

Clinical Evidence

No clinical data submitted; bench testing only.

Technological Characteristics

Air-cooled, diode-pumped, solid-state Nd:YAG laser; 532 nm wavelength; 50 mW to 3.0 W output. Includes laser console, footswitch, remote control, and various delivery adapters/probes. Features adjustable exposure times, pulse counters, and aiming beams. Class II device.

Indications for Use

Indicated for patients requiring ocular photocoagulation for anterior/posterior segment pathologies, including diabetic retinopathy, choroidal neovascularization, retinal vein occlusion, age-related macular degeneration, retinal tears/detachments, retinopathy of prematurity, and glaucoma (iridotomy/iridectomy/trabeculoplasty). Used in ophthalmic surgery for retinal repairs, vitreoretinal surgery, and fluid aspiration/illumination during procedures.

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Predicate Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Ko52526 NOV 1 5 2005 #### 510 (k) Summarv # General Information: Submitter: Lumenis, Inc. 2400 Condensa Street Santa Clara, CA 95051 Contact Person: Tel: Fax: Karen Baker Tel : (408) 764-3603 (408) 764-3934 Fax: Summary Date of Preparation: September 12, 2005 #### Names: Proprietary Name: Common Name: Classification Name: Novus® 3000 Laser System and Delivery Devices Nd: YAG Laser Laser Instrument, Surgical, Powered (21 CFR 878.4810, Product Code 79 GEX) ### Predicate Devices: Novus® Varia (K022181) Novus® Spectra (K022327) LaserLink Zeiss Slit Lamp Delivery Adapters (LaserLink Z and Z-1000) (K022181; K022327, K032357) LaserLink HS Slit Lamp Laser Delivery Adapter (K022327, K032357) Lumenis 1000 Integrated Slit Lamp (K052129) Laser Indirect Ophthalmoscope (Heine and Keeler models) (K022181, K022327, K032357) Lumenis Acculite Endophotocoagulation Probe Delivery System (Acculite Endoprobe/Endokit) (K022181, K022327, K032357) Illuminating EndoOcular Probe (K022357, K931784) Aspirating EndoOcular Probe (K022357, K931072) Lumenis's Novus® 3000 Laser System and Delivery Devices is substantially equivalent to the Lumenis Novus® Varia and the Lumenis Novus® Spectra manufactured and distributed by Lumenis, Inc. Salt Lake City, Utah. The Novus® 3000 Ophthalmic Laser System with Delivery Devices and Accessories share the same intended uses, indications for use and the same or similar technological characteristics including: treatment wavelengths, laser active medium, pumping system, aiming beam, mode of operation, exposure duration, power, treatment intervals, spot sizes, controls and displays, laser energy delivery control (foot switch), and delivery systems as the predicate devices identified above. ### Device Description 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. {1}------------------------------------------------ Kośź, 76 ### Intended 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; 1 - 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 eves 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 The Acculite EndoOcular Probe is indicated or 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. {2}------------------------------------------------ iKos226 # Technological Characteristic Similarities The Novus 3000 Laser System and Delivery Devices is similar in intended use and mode of operation to the Lumenis Novus® Varia and the Lumenis Novus® Spectra. The Novus 3000 Laser System and Delivery Devices, the Novus Varia and the Novus Spectra all utilize a frequency doubled ND: YAG, diode-pumped solid state system. The laser control system. mode of operation, laser actuation, pulse counter, treatment intervals, aiming beam and the exposure times, which are adjustable in variable increments, are the same for the predicate devices as well as the Novus 3000® Laser System. In addition, the same Delivery Systems are available for the predicate devices and the Novus 3000. ### Performance Data: 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)]. ### Conclusion: The Novus® 3000™ with Delivery Devices is substantially equivalent to the Novus Varia Ophthalmic Laser and Delivery Devices and the Novus Spectra Laser with Delivery Devices. The Novus® 3000™ Laser with Delivery Devices share intended use, indications for use, and technological characteristics as the predicate ophthalmic laser systems. {3}------------------------------------------------ Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo features a stylized depiction of a human figure, with three abstract lines representing the head, body, and legs. The figure is enclosed within a circular border, with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" arranged around the upper half of the circle. Public Health Service NOV 1 5 2005 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Karen Baker Manager, Regulatory Affairs Lumenis, Inc. 2400 Condensa Street Santa Clara, California 95051 Re: K052526 Trade/Device Name: Novus 3000 Laser and Delivery Devices Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: September 12, 2005 Received: September 14, 2005 Dear Ms. Baker: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {4}------------------------------------------------ ### Page 2- Karen Baker This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Barbare Buchup Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # Indications for Use K052526 510(k) Number (if known): Novus 3000 Laser and Delivery Devices Device Name: 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; r - 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. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Charbare fruchnd Division Sign here and Neurological Devices 510(k) Number K052526 {6}------------------------------------------------ # Indications for Use 510(k) Number (if known): Device Name: 002126 Novus 3000 Laser and Delivery Devices Indications For Use, Continued: #### 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. Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use _ (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) barban Buehup Neurological Devic 5101 Number K052524 Page 2 of 2
Innolitics
510(k) Summary
Decision Summary
Classification Order
Enter a record ID and click Load to view the document.
100%