(115 days)
No
The document describes a laser system for surgical procedures and does not mention any AI or ML components or functionalities.
Yes
The device is described as a "surgical laser" used for procedures like retinal photocoagulation, stapedectomy, and removal of vascular and pigmented lesions, which are all therapeutic interventions.
No
The device is a surgical laser used for various medical procedures (photocoagulation, removal of tissues, control of bleeding, etc.), which are therapeutic interventions, not diagnostic ones.
No
The device description clearly states it is a "solid state, frequency-doubled, green Nd: YAG surgical laser," which is a hardware device. It also mentions compatible hardware delivery devices like slit lamps and endoprobes.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this is a "surgical laser" used for "photothermolysis (photocoagulation) of soft tissue." This is a therapeutic device that directly interacts with the patient's tissue during a surgical procedure.
- Intended Use: The intended uses listed (retinal photocoagulation, stapedectomy, vascular lesion treatment, etc.) are all surgical procedures performed directly on the patient's body.
The device's function is to deliver laser energy for therapeutic purposes within the body, not to analyze samples taken from the body.
N/A
Intended Use / Indications for Use
The Medical Frequency Doubled YAG Laser is intended for use in otolaryngological, dermatological and ophthalmic surgical procedures. A complete list is contained in the Indications for Use Statement.
Ophthalmology:
- Retinal Photocoagulation .
- Pan Retinal Photocoagulation
- Endophotocoagulation
- Macular Treatments
- Laser Trabeculoplasty
Otolaryngology:
- Stapedectomy
- · Stapedotomy
- · Myringotomy
- · Lysis of adhesions
- Control of bleeding
- · Removal of acoustic neuromas ·
- · Soft tissue adhesion in micro/macro otologic procedures.
Dermatology:
- · Vascular lesion
- · Pigmented lesion
Product codes (comma separated list FDA assigned to the subject device)
HQF
Device Description
The Medical Frequency Doubled YAG Laser is a solid state, frequency-doubled, green Nd: YAG surgical laser. It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 532nm. LightLas LaserLink : Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared LightLas 532 retinal photocoagulator to allow use of the slit lamp to deliver 532 nm continuous wave laser energy for retinal photocoagulation.
Compatible delivery devices include: slit lamps, slit lamp adapters/ attachments, laser indirect ophthalmoscopes(LIO) and endoprobe.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ophthalmologic, Otolaryngologic, Dermatologic
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 Medical Frequency Doubled Y AG Laser System.
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.
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
510(K) Summary
SEP 1 8 2009
This is a 510(K) summary in accordance with CFR807.82(c).
A. Submitter Information:
Lightmed Corporation Submitter:
Address: NO.1-1, Lane1, Pao-An St. Sec. 3, Shulin City, Taipei Hsien 23861, Taiwan
Owner/Operator Number: Mr. Gary Lee, President / 9040850
Contact person: Anita Chen, Regulatory Affair
TEL: +886-2-2688-1726
FAX: +886-2-2676-4920
- B. Device Name:
Product Name: Medical Frequency Doubled YAG Laser Trade Name: LightLas 532
Trade Name: Digoxin 552
Common name: Ophthalmic Laser, Surgical Laser
Classification name:
86 HQF, Laser, Ophthalmic
79 GEX, Laser Powered Surgical Instrument
Regulation Number:
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
C. Predicate Device Names:
(1) Device Names: Novus Spectra Laser System (K022327)
(2) Device Names: Viridis Derma(K020071)
(3) Device Nambe: VariLite Laser System (K041930)
1
D. Device Description:
The Medical Frequency Doubled YAG Laser is a solid state, frequency-doubled, green Nd: YAG surgical laser. It's an instrument used in the photothermolysis (photocoagulation) of soft tissue at en emission wavelength of 532nm. LightLas LaserLink : Laser delivery adapter that may be coupled to each of the above Selecta models and connected to a currently cleared LightLas 532 retinal photocoagulator to allow use of the slit lamp to deliver 532 nm continuous wave laser energy for retinal photocoagulation.
Compatible delivery devices include: slit lamps, slit lamp adapters/ attachments, laser indirect ophthalmoscopes(LIO) and endoprobe.
The intended use has not changed from the predicate devices.
E. Intended Use:
The Medical Frequency Doubled YAG Laser is intended for use in otolaryngological, dermatological and ophthalmic surgical procedures. A complete list is contained in the Indications for Use Statement.
The intended use has not changed from the predicate devices.
Technological Characteristics summary & Substantial Equivalence F. The Medical Frequency Doubled YAG Laser has the same indications for use as the Irides-OcuLight TX (K062369). They have similar functional elements such as treatment wavelengths, pulse rates, 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.
-
G. Performance Data Summary:
The appropriate testing including safety, performance and functional testing to determine substantial equivalence of the Medical Frequency Doubled Y AG Laser System. -
H. Conclusion
The LightLas 532 is substantially equivalent to predicate devices currently legally marketed for the indication of retinal photocoagulation. laser trabeculoplasty. the treatment of vascular and pigmented skin lesions, and other laser treatments.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
SEP 1 8 2009
Lightmed Corporation % Ms. Anita Chen Regulatory Affairs NO, 1-1, Lane 1, Pao-An St. Sec. 3 Shulin City, Tapei Hsien 23861 Taiwan
Re: K091534
Trade/Device Name: Medical Frequency Doubled YAG Laser Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic laser Regulatory Class: Class II Product Code: HQF Dated: August 24, 2009 Received: August 26, 2009
Dear Ms. Chen:
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 avproval 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 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: registfation 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
3
Page 2 - Ms. Ànita Chen
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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Milliman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1114162011 101 บอง มเลเบแนน เมเนเนเนเน บร มหมุนบอนบน บร
Kogi 534 510(K) Number (if Known): ____________________________________________________________________________________________________________________________________________________
Product Name: Medical Frequency Doubled YAG Laser Trade Name: LightLas 532
Indications for Use:
Ophthalmology:
- Retinal Photocoagulation .
- Pan Retinal Photocoagulation
- Endophotocoagulation
- Macular Treatments
- Laser Trabeculoplasty
Otolaryngology:
- Stapedectomy
- · Stapedotomy
- · Myringotomy
- · Lysis of adhesions
- Control of bleeding
- · Removal of acoustic neuromas ·
- · Soft tissue adhesion in micro/macro otologic procedures.
Dermatology:
- · Vascular lesion
- · Pigmented lesion
The intended use has not changed from the predicate devices (K022327, K020071, K062369)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDR, Office of Device Evaluation (ODE)
| Prescription Use: | X OR Over-The-Counter Use: |
|---|---|
| (Per 21 CFR 801.109) |
Med RE Ol for MXM
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
| 510K_ENT_A4.doc | 66 |
|---|---|
| ----------------- | ---- |
| 510(k) Number | K091534 |
|---|---|
| --------------- | --------------------------------------------------------- |