(24 days)
Not Found
No
The summary describes a standard slit lamp biomicroscope and does not mention any AI or ML capabilities, image processing, or data-driven performance metrics.
No
The device is described as a diagnostic tool used to aid in the diagnosis of diseases or trauma, not to treat them.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segments."
No
The device description explicitly states it is an "AC-power slit lamp biomicroscope," which is a hardware device. The summary also mentions compliance with hardware-related standards like IEC 60601-1.
Based on the provided information, the Luxvision Slit Lamp is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. The description of the Luxvision Slit Lamp clearly states its intended use is for the "eye examination of the anterior eye segment," which is a direct examination of the patient's body, not a specimen taken from it.
- The device description and intended use focus on direct visualization and examination of the eye's structure. This is characteristic of an in vivo diagnostic device, not an in vitro one.
- There is no mention of analyzing biological samples, reagents, or laboratory procedures. These are key components of IVD devices.
Therefore, the Luxvision Slit Lamp is an in vivo diagnostic device used for direct examination of the eye.
N/A
Intended Use / Indications for Use
The Luxvision Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segments.
Product codes
HJO
Device Description
The Luxvision Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination There are 3 models LS880, LS1100, and LS1400. These models differ only in the supplied accessories. All models have the same operating characteristics and intended use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
anterior eye segment, from the cornea epithelium to the posterior capsule
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 USOphthalmic Luxvision Slit Lamp complies with the requirements of listed FDA Recognized Consensus Standards.
- ISO 10939:1998, Ophthalmic instruments -- Slit-lamp microscopes.
- IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety
The USOphthalmic Luxvision Slit Lamp is substantially equivalent to the 66 Vision-Tech YZ Slit Lamp that is legally marketed and distributed by Suzhou 66 Vision-Tech Co., LTD. This has been demonstrated through a 8-point technological comparison of features.
Because the USOphthalmic Luxvision Slit Lamp meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 886.1850 AC-powered slitlamp biomicroscope.
(a)
Identification. An AC-powered slitlamp biomicroscope is an AC-powered device that is a microscope intended for use in eye examination that projects into a patient's eye through a control diaphragm a thin, intense beam of light.(b)
Classification. Class II (special controls). The device, when it is intended only for the visual examination of the anterior segment of the eye, is classified as Group 1 per FDA-recognized consensus standard ANSI Z80.36, does not provide any quantitative output, and is not intended for screening or automated diagnostic indications, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
063410
Summary of Safety and Effectiveness for the Luxvision Slit Lamp
DEC - 7 2006
submitted by USOphthalmic 7255 NW 68th Street Unit # 9 Miami, FL 33186 Phone: (305) 969-4545
Ezequiel D. Lukin Contact Person: Device Trade Name: Luxvision Slit Lamp Common Name: Slit Lamp Biomicroscope, Slit-lamp, AC-powered per 21 CFR § 886.1850 Classification Name:
Identification of a Legally Marketed Predicate Device
The USOphthalmic Luxvision Slit Lamp is substantially equivalent to 66 Vision-Tech YZ Slit Lamp that is legally marketed and distributed by Suzhou 66 Vision-Tech Co., LTD pursuant to premarket notification K033190.
Device Description
The Luxvision Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination There are 3 models LS880, LS1100, and LS1400. These models differ only in the supplied accessories. All models have the same operating characteristics and intended use.
Intended Use
The Luxvision Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segments.
Summary of Technological Characteristics
An 8-point comparison of technological characteristics of the USOphthalmic Luxvision Slit Lamp and the predicate devices was performed. The devices were found to be substantially equivalent.
1
Summary of Performance Data
The USOphthalmic Luxvision Slit Lamp complies with the requirements of listed FDA Recognized Consensus Standards.
- ISO 10939:1998, Ophthalmic instruments -- Slit-lamp microscopes .
- . IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety
The USOphthalmic Luxvision Slit Lamp is substantially equivalent to the 66 Vision-Tech YZ Slit Lamp that is legally marketed and distributed by Suzhou 66 Vision-Tech Co., LTD. This has been demonstrated through a 8-point technological comparison of features.
Because the USOphthalmic Luxvision Slit Lamp meets the requirements of the stated standards and embody technological characteristics essentially identical to the predicate device, we believe the device is safe and effective and performs as well as or better than the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 7 2006
U. S. Ophthalmic LLC c/o Mr. Al Weisenborn 7255 NW 68th St. Unit #9 Miami, FL 33166
Re: K063416
Trade/Device Name: Luxvision Slit Lamp (Models LSL880, LSL 1100, and LSL 1400) Regulation Number: 21 CFR 886.1850 Regulation Name: Slit Lamp Regulatory Class: II Product Code: HJO Dated: November 3, 2006 Received: November 13, 2006
Dear Mr. Weisenborn:
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.
3
Page 2 – Mr. Al Weisenborn
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M.B. Eychlesheimer MD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
Page 1 of 1
0634 510(k) Number (if known):
Device Name: Luxvision Slit Lamp
Indications for Use:
The Luxvision Slit Lamp is an AC-power slit lamp biomicroscope intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affect the structural properties of the anterior eye segments.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daryl L. Kaufman
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K063416
Page 1 of 1
USOphthalmic
November 3, 2006