(26 days)
None
Not Found
No
The summary describes a standard diode laser system for surgical use and makes no mention of AI or ML capabilities, image processing, or data-driven performance metrics.
Yes
The device is intended for the treatment of pigmented and vascular lesions, which indicates a therapeutic purpose.
No
Explanation: The "Intended Use / Indications for Use" states the device is "intended for treatment," which indicates a therapeutic purpose rather than a diagnostic one. There is no mention of diagnosing conditions.
No
The device description explicitly states it is a "semiconductor diode laser operating at 810 + 20 microns," which is a hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of pigmented and vascular lesions, including leg veins. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a surgical laser. Surgical lasers are used for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information for diagnosis, monitoring, or screening.
- Reagents or test kits.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This device is used to directly treat a condition.
N/A
Intended Use / Indications for Use
The LaserLite Diode Surgical Laser is intended for treatment of pigmented and vascular lesions including leg veins.
Product codes
GEX
Device Description
The LaserLite Diode Laser System is a semiconductor diode laser operating at 810 + 20 microns.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
None. The specifications and indications for use of the LaserLite Diode Surgical Laser System are the same or very similar to those of the claimed predicate devices. The LaserLite Diode Surgical Laser has the same indications for use for which the claimed predicates have been cleared and has no additional indications for use. Because of this, performance data were not required.
Key Metrics
Not Found
Predicate Device(s)
Coherent LightSheer Diode Laser System, Iriderm DioLite 532 Laser System, Laserscope Aura Laser System
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
K98 1090
APR 21 1998
510(K) SUMMARY LASERLITE DIODÈ ŠURGICAL LASER SYSTEM
This 510(k) summary of safety and effectiveness for the diode laser system is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.
| Applicant: | LaserLite |
|---|---|
| Address: | 30-31 Union Wharf |
| Boston, MA 02109 | |
| Contact Person: | David F. Muller, Ph.D. |
| President | |
| Telephone: | 617-720-5254 |
| 617-720-5260 (fax) | |
| Preparation Date: | |
| (of the Summary) | March, 1998 |
| Device Name: | LaserLite Diode Surgical Laser System |
| Common Name: | Surgical Laser: GaAlAs Semiconductor Diode Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and in dermatology |
| (see: 21 CFR 878.4810). Product Code: GEX. Panel: 79. | |
| Legally marketed predicate device: | Coherent LightSheer Diode Laser System, Iriderm DioLite 532 Laser System, and |
| Laserscope Aura Laser System | |
| Description of the Device: | The LaserLite Diode Laser System is a semiconductor diode laser operating at 810 + 20 |
| microns. | |
| Indications for Use: | The LaserLite Diode Surgical Laser is intended for treatment of pigmented and vascular |
| lesions including leg veins. | |
| Comparison to: | The specifications of the LaserLite Diode Surgical Laser System are the same or very |
| similar to those of the claimed predicates. | |
| Performance Data: | None. The specifications and indications for use of the LaserLite Diode Surgical Laser |
| System are the same or very similar to those of the claimed predicate devices. The | |
| LaserLite Diode Surgical Laser has the same indications for use for which the claimed | |
| predicates have been cleared and has no additional indications for use. | |
| Because of this, performance data were not required. | |
| Conclusion: | Based on the foregoing, LaserLite believes that the LaserLite Diode Surgical Laser is |
| substantially equivalent to legally marketed predicate devices. |
Appendix E
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the eagle in a circular fashion. The logo is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 21 1998
David F. Muller, Ph.D ·President LaserLite 30-31 Union Wharf Boston, Massachusetts 02109
Re: K981090 Trade Name: LaserLite Diode Surgical Laser Requlatory Class: II Product Code: GEX Dated: March 25, 1998 Received: March 26, 1998
Dear Dr. Muller:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
2
Page 2 - Dr. Muller
This letter will allow you to begin marketing your device as described in your 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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D.
Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Kg81090 510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: LaserLite Diode Surgical Laser
Indications For Use:
The LaserLite Diode Surgical Laser is indicated for treatment of pigmented and vascular lesions including leg veins.
(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 810.09)
OR
Over-The-Counter Use __
(Division Sign-On)
Division of General Restorative Devices
510(k) Number K981090