(200 days)
Not Found
No
The description focuses on the hardware components and basic control mechanisms of a laser system, with no mention of AI, ML, image processing, or data-driven performance metrics.
Yes
The device is described as a "Surgical Laser System" intended for "removal of dark tattoo ink," which indicates it is used for medical treatment or procedures.
No
The text indicates the device is a surgical laser system intended for removal of dark tattoo ink, which is a treatment not a diagnostic function.
No
The device description clearly outlines a physical laser system with hardware components such as power supplies, optical deck, cooling system, keypad control panel, CRT, footswitch, and fiber optics. This is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "removal of dark tattoo ink." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a surgical laser system that delivers energy to the patient's tissue.
- 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.
Therefore, based on the provided information, the Orion Series Surgical Laser System is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Orion Series Surgical Laser System (Q-switched Nd: YAG configuration) is indicated for removal of dark tattoo ink, including blue and black.
The Orion Series Surgical Laser System (Q-switched Nd:YAG configuration) is intended for removal of dark tattoo ink, including blue and black
Product codes
GEX
Device Description
The Orion Series Surgical Laser System consists of a movable containing power supplies, a treatment laser on a solid optical deck, and a cooling system to dissipate the heat generated by the system. A keypad control panel with CRT enables the user to control the laser system operating parameters.
Surgical power is controlled via a footswitch. Laser power is emitted only when the footswitch is depressed. The delivery system is through fiber optics.
Five configurations are currently available:
12W KTP only, 208 VAC 12W KTP/30W Nd:YAG, 208 VAC 20W KTP only, 208 VAC 20W KTP/50W Nd:YAG,208 VAC 50W Nd:YAG only, 208 VAC
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Medlite™ Q-switched Nd: Y AG Laser System
Reference Device(s)
Not Found
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
§ 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
K 964818
JUN 17 1997
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS LASERSCOPE ORION SERIES SURGICAL LASER SYSTEM
REGULATORY AUTHORITY
Safe Medical Device Act of 1990, 21 CFR 807.92
COMPANY NAME/CONTACT:
Lisa McGrath Laserscope 3052 Orchard Drive San Jose, CA 95134 Phone: 408 943-0636 FAX: 408-943-1454
DEVICE TRADE NAME:
Orion Series Surgical Laser System
DEVICE COMMON NAME:
Laser Instrument, Surgical, Powered
DEVICE DESCRIPTION:
The Orion Series Surgical Laser System consists of a movable containing power supplies, a treatment laser on a solid optical deck, and a cooling system to dissipate the heat generated by the system. A keypad control panel with CRT enables the user to control the laser system operating parameters.
Surgical power is controlled via a footswitch. Laser power is emitted only when the footswitch is depressed. The delivery system is through fiber optics.
Five configurations are currently available:
12W KTP only, 208 VAC 12W KTP/30W Nd:YAG, 208 VAC 20W KTP only, 208 VAC 20W KTP/50W Nd:YAG,208 VAC 50W Nd:YAG only, 208 VAC
1
SUMMARY OF SAFETY AND EFFECTIVENESS, PAGE 2
DEVICE CLASSIFICATION:
The Orion Series Surgical Laser System has been classified as a Class II medical device by the OB/GYN, General, Plastic Surgery and ENT Device Advisory Panels.
PERFORMANCE STANDARDS:
દે
The Orion Series Surgical Laser System conforms with federal regulations and the performance standards 21 CFR 1040.10 and 1040.11 for medical laser systems.
INDICATIONS FOR USE STATEMENT:
The Orion Series Surgical Laser System (Q-switched Nd: YAG configuration) is indicated for removal of dark tattoo ink, including blue and black.
COMPARISON WITH PREDICATE DEVICE:
The Orion Series Surgical Laser System (Q-switched Nd:Y AG configuration) is substantially equivalent to the Medlite™ Q-switched Nd: Y AG Laser System, manufactured by Continuum Biomedical, Inc.
The risks and benefits for the Orion Series Surgical Laser System are comparable to the predicate device when used for similar clinical applications.
Since the Orion Series Surgical Laser System (Q-switched Nd:YAG configuration) is substantially equivalent with respect to indications for use, materials, method of operation and physical construction to the predicate device, we believe it clearly meets the requirements for substantial equivalence according to Section 510(k) guidelines. Safety and effectiveness are reasonably assured, therefore justifying 510(k) clearance for commercial sale.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of several curved lines that create the shape of the bird's wings and body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lisa McGrath Sr. Regulatory Affairs Specialist Lasescope . ..... ........ 3052 Orchard Drive San Jose, California 95134-2011
JUN 1 7 1997
Re:
K964818 Trade Name: Orion Series Surgical Laser System (Q-switched Nd: Y AG configuration) Regulatory Class: II Product Code: GEX Dated: March 18, 1997 Received: March 19, 1997
Dear Ms. McGrath:
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 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting vour device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
3
Page 2 - Ms. Lisa McGrath
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 anvertising 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,
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
4
INDICATIONS FOR USE STATEMENT
510(K) Number: 964818
Orion Series Surgical Laser System (Q-switched Nd:YAG configuration) Device Name:
Indications for Use:
The Orion Series Surgical Laser System (Q-switched Nd:YAG configuration) is intended for removal of dark tattoo ink, including blue and black
今
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (
or
uation (ODE)
(Division Sign-Off
Division of General Restorative Devices
510(k) Number K964818
Prescription Use
(per 21 CFR 801.109)
Over-The-Counter Use