(88 days)
Not Found
Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any descriptions of training or test sets typically associated with AI/ML device submissions.
Yes
The device is indicated for "panretinal photocoagulation and ablation of the ciliary processes," which are therapeutic procedures.
No
The device is indicated for therapeutic procedures (photocoagulation and ablation) and does not perform any diagnostic function.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the device is software-only or includes hardware components. The intended use (panretinal photocoagulation and ablation of ciliary processes) strongly suggests a hardware component (likely a laser or similar energy source) is involved, but without a description, this cannot be confirmed.
Based on the provided information, the LuxScope is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "panretinal photocoagulation and ablation of the ciliary processes." This describes a therapeutic procedure performed directly on a patient's eye, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Anatomical Site: The anatomical site is "panretinal, ciliary processes," which are parts of the eye. This further supports that the device is used directly on the patient.
- Lack of IVD Indicators: The description lacks any mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis based on sample analysis
Therefore, the LuxScope is a therapeutic medical device used for eye treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LuxScope is indicated for panretinal photocoagulation and ablation of the ciliary processes.
Product codes
HQF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retinal, ciliary processes
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 886.4390 Ophthalmic laser.
(a)
Identification. An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which is a stylized representation of a human figure. The emblem is composed of three curved lines that form the shape of a person's head and torso. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the emblem.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 21 1997
Mr. Joseph Ress *Authorized Representative Luxtec Corporation C/O Medical Device Regulatory Consultants 45 Pontiac Road Newton, Massachusetts 02168
K973193 Re:
Trade Name: Luxscope .. Regulatory Class: II Product Code: HQF Dated: August 24, 1997 Received: August 25, 1997
Dear Mr. Ress:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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. 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 - 1000 -
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition. FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
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Page 2 - Mr. Ress
not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely vours.
to seefa
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
STATEMENT FOR INDICATIONS FOR USE
Page 1 of 1
510(K) Number: K973193
Device Name: LuxScope
Indications for Use:
The LuxScope is indicated for panretinal photocoagulation and ablation of the ciliary processes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED )
Concurrance of CDRH, Office of Device Evaluation (ODE)
Perscription Use YES
OR
Over-The-Counter Use NO
padelfs
(Division Sign-Off) Division of General Restorative Devices 73193 10 510(k) Number