(272 days)
No
The summary describes a laser system with electronic controls and software for wavelength selection, but there is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies. The performance studies focus on bench testing and compliance with specifications, not on algorithmic performance.
Yes
The device is intended for "retinal and pan-retinal photocoagulation, endophotocoagulation, macular photocoagulation to treat leaking vessels, and laser trabeculoplasty," which are all therapeutic interventions for ophthalmic conditions.
No
The device is described as an "ophthalmic laser instrument" for procedures like "retinal and pan-retinal photocoagulation" and "laser trabeculoplasty," which are therapeutic treatments, not diagnostic processes.
No
The device description explicitly states it consists of a "Laser Console where the Laser is housed along with the Electronic Control system and Power Supplies and various Laser Delivery Units (LDU's)," indicating significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is an "ophthalmic laser instrument intended for use by ophthalmologists" for treating various eye conditions (retinal, pan-retinal, macular, trabeculoplasty). This involves direct treatment of the patient's body.
- Device Description: The description details a laser system with delivery units designed to apply laser energy to the eye.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device is a therapeutic medical device used for surgical procedures on the eye.
N/A
Intended Use / Indications for Use
LightLas577/670 Multi-Wavelength Medical Laser System is an ophthalmic laser instrument intended for use by ophthalmologists. The 577 nm wavelength laser is indicated for retinal and pan-retinal photocoagulation, endophotocoagulation, macular photocoagulation to treat leaking vessels, and laser trabeculoplasty. The 670 nm wavelength laser is indicated for retinal and pan-retinal photocoagulation. The intended use has not changed from the predicate device (K103547)
Product codes (comma separated list FDA assigned to the subject device)
HQF
Device Description
LightLas577/670 Multi-Wavelength Medical Laser System consists of a Laser Console where the 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. (K992836) .
- Sirilamp Attachment for CSO model SL990 (K992836) and other Haag Streit clones. .
- Sittlamp Attachment for Zeiss model SL30 Stitlamp (K862004) .
- Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 500. (K123316) ●
- Laser Indirect Ophthalmoscope (LIO) using a Keeler All pupil II (K854244) 0
- . Endophotocoagulation Handpieces (K122905)
The LightLas 577/670 Multi-Wavelength Medical Laser System may be used at either the 577 nm wavelength or the 670 nm wavelength. The 577 nm wavelength source can be delivered through both output ports (Ports 1 and 2) of the laser console, while the 670 mm wavelength source is delivered through Port 1 only. Users may choose either wavelength from a LCD touch screen, and only one output port and one wavelength may be selected for use at a time. Laser wavelength selection of the system is indicated on the panel and controlled by system software.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
retinal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ophthalmologists
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)
LightLas577/670 Multi-Wavelength Medical Laser System was evaluated according to the requirements of FDA recognized consensus standards (IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60825-1, IEC60601-1-4, IEC60601-2-22 and ISO14971).These tests and evaluations were performed at LightMed facility and at outside test facilities as required. Bench testing performance was completed, including the assembly, testing calibration and alignment of LightLasS77/670 laser console and laser delivery units. All test results demonstrated that performance of LightLas577/670 Multi-Wavelength Medical Laser System complies with specifications and requirements. The conclusions drawn from the performance testing of the LightLas 577/670 Multi-Wavelength Medical Laser System demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K992836, K862004, K123316, K854244, K122905
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
§ 886.4390 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 11 510(k) Summary or Statement
510(K) Summary .
ﺬ
This is 510(K) summary in accordance with CFR807.82(c).
| Submitter Information: | |||||
|---|---|---|---|---|---|
| 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 in Taiwan: Jocelyn Liu, Regulatory Affairs Officer | |||||
| FAX: +886-2-2676-4920 | |||||
- Device Name B.
Product Name: LightLas577/670 Multi-Wavelength Medical Laser System Common Name: Ophthalmic Laser, Surgical Laser Classification Name: 86 HQF, Laser, Ophthalmic
Regulation Name: 21 CFR 886.4390, Ophthalmic Laser Regulatory Class: II Performance standards: 21 CFR 1040.10 & 1040.11
C. Device Technological Characteristics to Predicate Device:
| Manufacturer | LightMed Corporation
LightLas532/670 | LightMed Corporation
LightLas577/670 |
|-------------------|-----------------------------------------|----------------------------------------------------------|
| 510K Number | K103547 | - |
| Lasing Medium | Frequency doubled
Nd:YAG/Diode | Semiconductor/Diode |
| Pulsing System | Continuous | Continuous |
| Output Wavelength | 532nm/670nm | 577nm/670nm |
| Micro Pulse | - | 10% Duty Cycle
(Power"On" 200μs,
Power"Off" 1800μs |
1
| | | from 0.01s-Continuous
Wave for 577 nm only |
|-----------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| Average Power(AP) | 2W/0.7W | 2W/0.7W |
| Laser Safety Class | 4/IV | 4/IV |
| Exposure Sections (t) | 0.01s to continuous | 0.01s to continuous |
| Cooling Method | Solid State Cooling with
thermoelectric (Peltier)
heat pump | Solid State Cooling
with thermoelectric
(Peltier) heat pump |
| Aiming Beam: | Coaxial with treatment beam | |
| Aiming Beam: Type | Red Laser Diode | Red Laser Diode |
| Aiming Beam: Wavelength | 635-650nm (Red) | 635-650nm (Red) |
| Aiming Laser power | Maximum of 1.0mW | Maximum of 1.0mW |
| Laser Safety Class | 2/II | 2/II |
| Power requirements: Voltage | 100 to 240 Vac | 100 to 240 Vac |
D. Device Description
LightLas577/670 Multi-Wavelength Medical Laser System consists of a Laser Console where the 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. (K992836) .
- Sirilamp Attachment for CSO model SL990 (K992836) and other Haag Streit clones. .
- Sittlamp Attachment for Zeiss model SL30 Stitlamp (K862004) .
- Laser Indirect Ophthalmoscope (LIO) using a Heine Omega 500. (K123316) ●
- Laser Indirect Ophthalmoscope (LIO) using a Keeler All pupil II (K854244) 0
- . Endophotocoagulation Handpieces (K122905)
The LightLas 577/670 Multi-Wavelength Medical Laser System may be used at either the 577 nm wavelength or the 670 nm wavelength. The 577 nm wavelength source can be delivered through both output ports (Ports 1 and 2) of the laser console, while the 670 mm wavelength source is delivered through Port 1 only. Users may choose either wavelength from a LCD touch screen, and only one output port and one wavelength may be selected for use at a time. Laser wavelength selection of the system is indicated on the panel and controlled by system software.
- E. Intended Use:
LightLas577/670 Multi-Wavelength Medical Laser System is an ophthalmic laser
2
instrument intended for use by ophthalmologists. The 577 nm wavelength laser is indicated for retinal and pan-retinal photocoagulation, endophotocoagulation, macular photocoagulation to treat leaking vessels, and laser trabeculoplasty. The 670 nm wavelength laser is indicated for retinal and pan-retinal photocoagulation. The intended use has not changed from the predicate device (K103547)
Substantial Equivalence F.
LightLas577/670 Multi-Wavelength Medical Laser System has the same intend use, general design and fundamental scientific technology as the predicate device (K103547) Also the operating controls and functions are equivalent to the product. 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.
The difference in specifications of LightLas577/670 and LightLas532/670 (K103547) is that LightLas577/670 is based upon LightLas532/670 (K103547) with a modification of laser sources and corresponded control boards which causes different laser outputs. LightMed Corporation has demonstrated by evaluation of LightLas577/670 that modifications to current predicate devices are effective and safe.
There are no new hazards introduced by the Laser System as compared with the predicate devices.
Performance Data: ও
LightLas577/670 Multi-Wavelength Medical Laser System was evaluated according to the requirements of FDA recognized consensus standards (IEC60601-1, IEC60601-1-1, IEC60601-1-2, IEC60825-1, IEC60601-1-4, IEC60601-2-22 and ISO14971).These tests and evaluations were performed at LightMed facility and at outside test facilities as required.
Bench testing performance was completed, including the assembly, testing calibration and alignment of LightLasS77/670 laser console and laser delivery units. demonstrated that performance of LightLas577/670 test results All Multi-Wavelength Medical Laser System complies with specifications and requirements.
The conclusions drawn from the performance testing of the LightLas 577/670 Multi-Wavelength Medical Laser System demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609
Silver Spring, MD 20993-0002
September 26, 2013
Lightmed Corporation Ms. Jocelyn Liu Regulatory Affairs Coordinator No. 1-1. Lane 1. Pao-An St. Sec. 3. Shulin District, New Taipei City 23861, Taiwan
Re: K124043
Trade/Device Name: LightLas 577/670 Multi-Wavelength Medical Laser System Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: August 16, 2013 Received: August 23, 2013
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.
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
4
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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 vours.
Deborah Falls -S
for 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
5
Indications for Use Statement as Requested by FDA
510(K) Number (if Known): Product Name: LightLas577/670 Multi-Wavelength Medical Laser System Trade Name: LightLas 577/670
Indications for Use:
LightLas 577/670 is an ophthalmic laser instrument intended for use by ophthalmologists. The 577 mm wavelength laser is indicated for retinal and pan-retinal photocoagulation. endophotocoagulation, macular photocoagulation to treat leaking vessels. and laser trabeculoplasty. The 670 mm wavelength laser is indicated for retinal and pan-retinal photocoagulation.
The intended use has not changed from the predicate devices (K103547)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDR, Office of Device Evaluation (ODE)
Prescription Use: __ X (Per 21 CFR 801.109)
OR Over-The-Counter Use:
Charles Chilano 2013.09 26 14:53
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K124043