(336 days)
No
The document describes a laser system for ophthalmology and does not mention any AI or ML components in the device description, intended use, or performance studies.
Yes
The device is a medical laser system used for various ophthalmic procedures such as retinal photocoagulation and laser trabeculoplasty, which are treatments for diseases of the eye.
No
Explanation: The device is a laser system for photocoagulation and trabeculoplasty in ophthalmology, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly details hardware components such as a Laser Console, Multi-Wavelength Laser, Electronic Control system, Power Supplies, and various Laser Delivery Units (LDUs) like slitlamp attachments, a Laser Indirect Ophthalmoscope, and endophotocoagulation handpieces. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description and Intended Use: The description clearly states that this device is a laser system used for ophthalmology procedures performed directly on the patient's eye. The procedures listed (Retinal Photocoagulation, Laser Trabeculoplasty, etc.) are all therapeutic or surgical interventions performed in vivo (within the living body).
- No Mention of Specimens: There is no mention of collecting or analyzing any specimens from the patient.
- No Mention of Laboratory Use: The device is described as being used with slitlamps and indirect ophthalmoscopes, which are clinical tools used in an ophthalmologist's office or operating room, not typically in a laboratory setting for specimen analysis.
Therefore, this device is a therapeutic medical device used for treating conditions of the eye, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The LightLas 532 is an Ophthalmic Laser intended to coagulate or burn structures within the patient's eye and is suitable for performing the following clinical procedures: 532nm Laser: Retinal Photocoagulation Pan Retinal Photocoagulation Endophotocoagulation Macular photocoagulation to treat leaking vessels Laser Trabeculoplasty 670nm Laser: Retinal/Pan Retinal Photocoagulation The intended use has not changed from the predicate devices.
Product codes
HQF, GEX
Device Description
The LightLas 532/670 system consists of a Laser Console where the Multi-Wavelength Laser is housed along with the Electronic Control system and Power Supplies and various Laser Delivery Units (LDU's). The LDU's include: - Slitlamp Integrated into CSO model SL980. . - Slitlamp Attachment for CSO model SL990 and other Haag Streit clones. . - Slitlamp Attachment for Zeiss model SL30 Slitlamp . - . Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 180 BIO. - Endophotocoagulation handpieces (Endoprobes) .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's 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)
The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the LightLas 532/670 Multi-Wavelength Medical Laser system.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K052777, K022181, K042785, K091534
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
Section 3 510(k) Summary or Statement
510(K) Summary
This is 510(K) summary in accordance with CFR807.82(c).
. . . . .
Submitter Information: A.
| Submitter: | LightMed Corporation |
|---|---|
| Address: | NO.1-1,Lane1, Pao-An St. Sec. 3, Shulin Dist., New Taipei City 23861, Taiwan |
| Owner/ Operation Number: | Mr. Gary Lee, President / 9040850 |
| Contact person: | Jocelyn Liu, Regulatory Affair |
TEL: +886-2-2688-1726
FAX: +886-2-2676-4920
B. Device Name
Product Name: LightLas Multi-Wavelength Medical Laser System Trade Name: LightLas 532/670
Common Name: Ophthalmic Laser, Surgical Laser
Classification Name:
86 HQF, Laser, Ophthalmic
79 GEX, Laser Power Surgical Instrument
Regulation Name:
21 CFR 886.4390, Ophthalmic Laser
21 CFR 878-4810, Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II
Performance standards: 21 CFR 1040.10 & 1040.11
Predicate Device Names: C.
(1) Ellex Integre Duo (K052777)
(2) Lumenis Nevus@ Varia'M Ophthalmic Laser and Delivery Devices (K022181)
(3) Nidek Multi Color Laser Photocoagulator Model MC-300 (K042785)
(4) LightMed Lightlas532 (K091534)
D. Device Description
The LightLas 532/670 system consists of a Laser Console where the Multi-Wavelength Laser is housed along with the Electronic Control system and Power Supplies and
1
various Laser Delivery Units (LDU's). The LDU's include:
- Slitlamp Integrated into CSO model SL980. .
- Slitlamp Attachment for CSO model SL990 and other Haag Streit clones. .
- Slitlamp Attachment for Zeiss model SL30 Slitlamp .
- . Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 180 BIO.
- Endophotocoagulation handpieces (Endoprobes) .
E. Intended Use
The LightLas 532 is an Ophthalmic Laser intended to coagulate or burn structures within the patient's eye and is suitable for performing the following clinical procedures: 532nm Laser:
- · Retinal Photocoagulation
- · Pan Retinal Photocoagulation
- · Endophotocoagulation
- · Macular photocoagulation to treat leaking vessels
- Laser Trabeculoplasty
670nm Laser:
-
· Retinal/Pan Retinal Photocoagulation
The intended use has not changed from the predicate devices. -
F. Technological Characteristics summary & Substantial Equivalence
The LightMed Multi-wavelength Medical Laser system of ophthalmic lasers, LightLas 532/670, has the same intended use, general design and fundamental scientific technology as the predicate devices (K052777, K022181, K042785, and K091534). Also the operating controls and functions are equivalent to these products. They have the same functional elements such as treatment wavelengths, treatment power, spot size and cooling system. Control systems such as the door interlock, and the safety systems and displays are constantly monitored in these systems for user intervention during a procedure or maintenance. There are no new hazards introduced by the Laser System as compared with the predicate devices. Therefore the Clinical effectiveness of the LightLas 532/670 is equivalent to the previously marketed products as these specifications are the key factors that will affect the treatment modality.
G. Performance Data Summary:
The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the LightLas 532/670 Multi-Wavelength Medical Laser system.
.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
NOV - 3 2011
LightMed Corporation % Ms. Jocelyn Liu Regulatory Affair No. 1-1, Lane 1, Pao-An St. Sec. 3, Shulin Dist., New Taipei City 23861 Taiwan
Re: K103547
Trade/Device Name: LightLas Multi-Wavelength Medical Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF, GEX Dated: September 28, 2011 Received: October 05, 2011
Dear Ms. Liu:
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.
3
Page 2 - Ms. Jocelyn Liu
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); 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/ReportaProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement as Requested by FDA
510(K) Number (if Known): ____________________________________________________________________________________________________________________________________________________ 103547
Product Name: LightLas Multi-Wavelength Medical Laser System Trade Name: LightLas 532/670
Indications for Use:
Ophthalmology:
532nm Laser ··
- · Retinal Photocoagulation
- Pan Retinal Photocoagulation
- · Endophotocoagulation
- · Macular photocoagulation to treat leaking vessels
- Laser Trabeculoplasty
670nm Laser
- Retinal/Pan Retinal Photocoagulation
The intended use has not changed from the predicate devices (K052777, K022181, K042785, and K091534)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDR, Office of Device Evaluation (ODE)
Prescription Use:
Over-The-Counter Use: OR
(Per 21 CFR 801.109)
Nil R. Patil for mxm
ivision of Surgical, Orthopedic, nd Restorative Devices
510(k) Number_