(90 days)
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Not Found
No
The summary describes a laser photocoagulator and its intended uses and delivery systems. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is indicated for "all retinal photocoagulation procedures" and "glaucoma procedures, such as laser trabeculoplasty and iridotomy," which are medical treatments.
No
The device is described as a photocoagulator indicated for treatment procedures (e.g., retinal photocoagulation, laser trabeculoplasty, iridotomy), not for diagnosis.
No
The device is described as a "Laser Photocoagulator" and is used in combination with various delivery systems like slitlamps and probes, indicating it is a hardware device that emits a laser.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a laser photocoagulator used for treating conditions of the retina and glaucoma. This is a therapeutic device that directly interacts with the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
The LightLas 810 is a therapeutic device used for surgical procedures, not for analyzing biological samples outside the body.
N/A
Intended Use / Indications for Use
The LightLas 810 Infrared Laser Photocoagulator is indicated for all retinal photocoagulation procedures, such as limited and pan-retinal, transpupillary laser photocoagulation, endophotocoagulation and transscleral photocoagulation, and glaucoma procedures, such as laser trabeculoplasty and iridotomy. The LightLas 810 is used in combination with various delivery systems, such as slitlamps, binocular indirect ophthalmoscopes, endoprobes and transscleral probes.
Product codes
GEX, HQF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
retinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.
Public Health Service.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
LightMed Corporation Ms. Irene Lin Regulatory Coordinator No.1-1, Lane 1, Pao-An St. Sec 3 Shulin City Taipei, Taiwan 238
Re: K021538
Trade/Device Name: LightLas 810 Infrared Laser Photocoagulator Regulation Number: 878.4810 and 886.4390 Regulation Name: Laser surgical Instrument for Use in General and Plastic surgery and in dermatology and Opthalmic Laser Regulatory Class: Class II Product Code: GEX, HQF Dated: May 3, 2002 Received: May 10, 2002
Dear Ms. Lin:
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 mav 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Irene Lin
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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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Mark McMillan
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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2.Indications for Use
510(k) Number: K021538
Device Name: LightLas 810 Infrared Laser Photocoagulator
Indications For Use:
The LightLas 810 Infrared Laser Photocoagulator is indicated for all retinal photocoagulation procedures, such as limited and pan-retinal, transpupillary laser photocoagulation, endophotocoagulation and transscleral photocoagulation, and glaucoma procedures, such as laser trabeculoplasty and iridotomy. The LightLas 810 is used in combination with various delivery systems, such as slitlamps, binocular indirect ophthalmoscopes, endoprobes and transscleral probes.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use __
(Per 21 CFR 801.109)
Over-The-Counter-Use __
(Optional format 1-2-96)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number __[K021538](https://510k.innolitics.com/search/K021538)
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