(84 days)
No
The description focuses on laser technology and its application for photocoagulation, with no mention of AI or ML capabilities.
Yes
The device is described as "intended for use in the treatment of ocular pathology" and lists specific treatments like "photocoagulation" for various conditions.
No
The device is intended for the treatment of ocular pathology through photocoagulation, not for diagnosis.
No
The device description explicitly states it is a "Laser System" comprised of hardware components including a laser console, control and display panel, remote control, external door interlock plug, and footswitch.
Based on the provided text, the Vision One Laser System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Vision One Laser System's Intended Use: The text clearly states the Vision One Laser System is intended for the treatment of ocular pathology through photocoagulation. This is a therapeutic intervention performed directly on the patient's eye, not a diagnostic test performed on a sample outside the body.
- Device Description: The description details a laser system used for treatment, not for analyzing biological samples.
Therefore, the Vision One Laser System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Vision One Laser System is intended for use in the treatment of ocular pathology. The Vision One Laser System green, yellow, and red wavelengths are 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.
- Retinal tears and detachments.
- Retinopathy of prematurity
- Iridotomy, iridectomy, and trabeculoplasty in angle closure. glaucoma and open angle glaucoma
Product codes
GEX, HQF
Device Description
The Vision One Laser System is classified as a Class IV laser by the Center for Devices and Radiological Health of the Food and Drug Administration. The Vision One Laser System is intended for use in the treatment of ocular pathology. The system's green, yellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments. The Vision One Laser System will incorporate the newest laser technology - Optically Pumped Semiconductor Laser (OPSL) in additions to Nd:YAG which are both subsets of DPSS (Diode Pumped Solid State Laser).
The system shall be configurable so that any combination of up to three (3) treatment lasers can be installed and used.
The Vision One Laser System is comprised of the laser console, control and display panel, remote control, an external door interlock plug, & footswitch.
The following accessories & delivery devices are compatible and available for the Vision One Laser System: Lumenis 1000 Integrated Slit Lamp, Lumenis InSight Integrated Slit Lamp, LaserLinks: SL130 Zeiss Slit Lamp, 30SL Zeiss Slit Lamp, 20SL Zeiss Slit Lamp, 125SL Zeiss Slit Lamp, Haag Streit Slit Lamp, Lumenis LaserLink S, Eye Safety Filter for all LaserLinks listed, Single and Dual Endo Kits for Zeiss and Leica / Wild microscopes, Endo Kit for Leica M840, Keeler LIO (Laser Indirect Ophthalmoscope), & Heine LIO (Laser Indirect Ophthalmoscope).
The Vision One Laser System uses the same types of delivery devices and accessories as the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ocular (anterior and posterior segments), retina, choroid
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence has been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
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Image /page/0/Picture/0 description: The image shows the Lumenis logo. The logo consists of a stylized letter "L" inside a black circle on the left, followed by the word "LUMENIS" in a bold, sans-serif font. Below the word "LUMENIS" is the tagline "Enhancing Life. Advancing Technology."
K11/215 Page ① of ③
5. 510(k) SUMMARY
510(k) Summary
JUL 25 2011
Submitter General Information: .
| Device Owner Name: | Lumenis, Inc. |
|---|---|
| Address: | 3959 West 1820 South |
| Salt Lake City, UT 84104 | |
| Contact: | Jace R. McLane |
| Phone: | 801-656-2328 |
| Fax: | 801-656-2627 |
| Date of Preparation: | April 29, 2011 |
II. Device Name:
| Trade Name: | Vision One Laser System |
|---|---|
| Common/Usual Name(s): | Surgical Laser, Ophthalmic Laser |
| Class: | Class II |
| Classification Name(s): | 79 GEX, Laser Powered Surgical Instrument |
| 86 HQF, Laser, Ophthalmic | |
| CFR Reference: | 21 CFR § 878.4810, Laser surgical instrument for use in |
| general and plastic surgery and in dermatology | |
| 21 CFR § 886.4390, Ophthalmic Laser |
III. Predicate Device Name(s):
Novus Varia Laser System (K022181) Trade Name(s):
IV. Device Description:
The Vision One Laser System is classified as a Class IV laser by the Center for Devices and Radiological Health of the Food and Drug Administration. The Vision One Laser System is intended for use in the treatment of ocular pathology. The system's green, yellow, and red wavelengths are indicated for use in photocoagulation of both anterior and posterior segments. The Vision One Laser System will incorporate the newest laser technology - Optically Pumped Semiconductor Laser (OPSL) in additions to Nd:YAG which are both subsets of DPSS (Diode Pumped Solid State Laser).
The system shall be configurable so that any combination of up to three (3) treatment lasers can be installed and used.
The Vision One Laser System is comprised of the laser console, control and display panel, remote control, an external door interlock plug, & footswitch.
Lumenis, Inc. 3959 West 1820 South Salt Lake City, UT 84104, USA
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Image /page/1/Picture/0 description: The image shows the logo for Lumenis. The logo consists of a stylized "L" inside of a circle, followed by the word "LUMENIS" in all caps. Below the word "LUMENIS" is the tagline "Enhancing Life. Advancing Technology."
K11/2/3 Page (2) of (3)
The following accessories & delivery devices are compatible and available for the Vision One Laser System: ·
Lumenis 1000 Integrated Slit Lamp, Lumenis InSight Integrated Slit Lamp, LaserLinks: SL130 Zeiss Slit Lamp, 30SL Zeiss Slit Lamp, 20SL Zeiss Slit Lamp, 125SL Zeiss Slit Lamp, Haag Streit Slit Lamp, Lumenis LaserLink S, Eye Safety Filter for all LaserLinks listed, Single and Dual Endo Kits for Zeiss and Leica / Wild microscopes, Endo Kit for Leica M840, Keeler LIO (Laser Indirect Ophthalmoscope), & Heine LIO (Laser Indirect Ophthalmoscope).
The Vision One Laser System uses the same types of delivery devices and accessories as the predicate device.
V. Intended Use:
The Vision One Laser System is intended for use in the treatment of ocular pathology. The Vision One Laser System green, yellow, and red wavelengths are 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 .
- Retinal tears and detachments .
- . Retinopathy of prematurity
- Iridotomy, iridectomy, and trabeculoplasty in angle closure . glaucoma and open angle glaucoma
VI. Substantial Equivalence Summary:
The Vision One Laser System has the same intended use as the predicate device -Novus Varia Ophthalmic Laser (K022181). It uses the same fundamental scientific technology as the predicate device. In addition, Vision One Laser System and the predicate device have the same patient population, principles of operation, method of energy delivery, critical materials, and basal design.
VII. Performance Data:
The appropriate testing, including safety, performance and functional testing, to determine substantial equivalence has been conducted.
Lumenis, Inc. 3959 West 1820 South Salt Lake City, UT 84104, USA
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K11/13 page 3 of (3)
VIII. Conclusion:
The subject device, the Vision One Laser System, has the same intended use, general design, and fundamental scientific technology as the predicate device (K022181).
The Vision One Laser System uses technology substantially equivalent to the Novus Varia Ophthalmic Laser (K022181). There are no new hazards introduced by the Vision One Laser System as compared with the predicate device.
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Lumenis, Inc. 3959 West 1820 South Salt Lake City, UT 84104, USA
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Food and Drug Administration , 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Lumenis, Inc. % Ms. Jace R. McLane 3959 West 1820 South Regulatory Affairs Specialist Salt Lake City, Utah 84104
JUL 2 5 2011
Re: K111213
Trade/Device Name: Vision One Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II
Product Code: GEX Dated: July 15, 2011 Received: July 18, 2011
Dear Ms. McLane:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Ms. Jace R. McLane
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcestorYou/Industry/default.htm.
Sincerely yours,
Eunel Keith
for Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. INDICATIONS FOR USE STATEMENT
Indications for Use
KILLE 510(k) Number (if known):
Device Name: Vision One Laser System
Indications for Use:
The Vision One Laser System is intended for use in the treatment of ocular pathology. The Vision One Laser System green, vellow, and red wavelengths are 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 .
- . Retinal tears and detachments
- Retinopathy of prematurity .
- Iridotomy, iridectomy, and trabeculoplasty in angle closure glaucoma and . open angle glaucoma
Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page U of O
Neil R.P. Oden for man
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K111213
Page 8 of 25
Lumenis, Inc. 3959 West 1820 South .Salt Lake City, UT 84104, USA
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