(90 days)
Not Found
No
The summary describes a laser photocoagulation device and its components (handpiece, fiber, connector, jacket). There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The intended use and device description are purely focused on the physical delivery of laser energy.
Yes.
The device is used to perform photocoagulation treatments inside the eye, which is a medical procedure to treat conditions such as retinal diseases.
No
This device is indicated for performing photocoagulation treatments within the eye, which is a therapeutic procedure, not a diagnostic one. It is a tool for treatment delivery, not for pathological assessment or diagnosis.
No
The device description explicitly lists hardware components such as a handpiece, fiber, connector, and plastic jacket.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The provided description clearly states the device is used for "PERFORMING PHOTOCOAGULATION TREATMENTS INSIDE THE EYE LASER". This is a therapeutic procedure performed on the patient's body, not a diagnostic test on a specimen.
- Intended Use: The intended use is for surgical interventions and treatments within the eye, not for analyzing biological samples.
Therefore, based on the provided information, this device is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
This device is indicated for use to perform laser photocoagulation treatments inside the eye (i.e., panretinal photocoagulation, macular treatments, endophotocoagulation to ciliary processes, laser trabeculoplasty), during surgical interventions (e.g.: trans pars plana vitrectorny). The operating wavelength is 514 to 532 nm.
Product codes
GEX
Device Description
This device consists of the following parts already connected to each other:
- Handpiece with either a 20G or a 25G extension that holds the tip of the fiber and guides it inside the eye. - 6 ft fiber.
- A special connector that attaches the fiber end to the laser source.
- A flexible plastic jacket covers the length of the fiber.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
inside the eye
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)
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
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.
0
510(k) Summary As Required by 21 section 807.92 ( c )
AUG 2 0 2002
1-Submitter Name: OphthalMed LLC
1308 Morningside Park Dr 2-Address:
Alpharetta, GA 30022 USA
3-Phone: (678) 908- 8180
(425) 795- 9341 4-Fax:
5-Contact Person: Jay Mansour
6-Date summary prepared: April 8th, 2002
7-Device Trade or Proprietary Name: 20g and 25g SMA Laser Fibers
8-Device Common or usual name: Ophthalmic laser
9-Device Classification Name: Ophthalmic laser
10-Substantial Equivalency is claimed against the following device:
LightLas 532 Ophthalmic Photocoagulator Laser from Light med Corporation (510k #K010372) Refer to Appendix 1 for details.
11-Description of the Device:
This device consists of the following parts already connected to each other:
- Handpiece with either a 20G or a 25G extension that holds the tip of the fiber and guides it inside the eye. - 6 ft fiber.
- A special connector that attaches the fiber end to the laser source.
- A flexible plastic jacket covers the length of the fiber.
12-Intended use of the device:
This device is indicated for use to perform laser photocoagulation treatments inside the eye (i.e., panretinal photocoagulation, macular treatments, endophotocoagulation to ciliary processes, laser trabeculoplasty), during surgical interventions (e.g.: trans pars plana vitrectorny). The operating wavelength is 514 to 532 nm.
13-Safety and Effectiveness of the device:
This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)
14-Summary comparing technological characteristics with other predicate device:
Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached.
1
| FDA file reference number | 510k 010372 |
|---|---|
| Attachments inside notification | |
| submission file | Appendix 1 to 5 |
| TECHNOLOGICAL | |
| CHARACTERISTICS | Comparison result |
| Indications for use | Identical |
| Target population | Identical |
| Design | Similar |
| Materials | Similar |
| Performance | Identical |
| Sterility | Similar (Ethylene Oxide) |
| Biocompatibility | Similar |
| Mechanical safety | Similar |
| Chemical safety | Similar |
| Anatomical sites | Identical |
| Human factors | Identical |
| Energy used and/or delivered | Identical |
| Compatibility with environment | |
| and other devices | Identical |
| Where used | Identical |
| Standards met | Similar |
| Electrical safety | Identical (not applicable) |
| Thermal safety | Identical (not applicable) |
| Radiation safety | Identical (not applicable) |
.
24
P8
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 0 2002
Mr. Jay Mansour Director, QA/RA OpthalMed LLC 1308 Morningside Park Drive Alpharetta, Georgia 30022
Re: K021696
Trade/Device Name: 20G SMA Laser Fiber, Model LF20; 25G SMA Laser Fiber, Model LF25 Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: GEX Dated: May 16, 2002 Received: May 22, 2002
Dear Mr. Mansour:
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. Iisting 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. Jay Mansour
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" (21CFR 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 A. Wilkerson
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
4
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (il known): 502 1696 (20g & 25 g Device Name: SHA LASER FINER Indications For Use:
THIS DEVICE IS INDICATED FOR USE TO PERFER 1 PHOTOCo.9 GULATION TREATHENTS INSUDE THE EYE LASER ાં. ૮ . PANKETINAL PHOTOCOAGULATION, MACULAR TREATHENTS, ENDO PHOTO COLLIATION TO CILIARY PROCESSES, LASER TRABECUPLASTY ) , DURING SURGEAL INTERVENTIONS e g .: TRANS PARS PLANA VITRECTOry Si4 To 532 nm THE OPERATING WAVELENGTH IS
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark A. Milliman
Division Sign Off
ivision Sign-Off) on of General, Restorative and Neurological
Prescription Use.............................................................................................................................................................. 216 9 Vest - 11
(Optional Formal 1-2-96)
p143