(36 days)
Not Found
No
The description mentions "precise computer control motion" but does not include any terms or concepts related to AI or ML, such as learning, training, algorithms, or data analysis for decision-making.
Yes
The device is intended to be used with a laser beam for the "treatment of any soft tissue, including, ablation, vaporization and coagulation of soft tissue on the skin," which describes therapeutic procedures.
No
The device is described as an accessory to manipulate a laser beam for treatment (ablation, vaporization, coagulation) of soft tissue, not for diagnosing conditions.
No
The device description explicitly states "LightScan is a hand held device" and describes its function in manipulating and placing a laser beam, indicating it is a physical hardware accessory, not solely software.
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 Function: The LightScan accessory device is used to manipulate and place a laser beam directly onto the skin for therapeutic purposes (ablation, vaporization, coagulation of soft tissue). It is a tool for performing a medical procedure on a living patient, not for analyzing a sample taken from a patient.
- Intended Use: The intended use clearly states it's for "treatment of any soft tissue... on the skin." This is a therapeutic application, not a diagnostic one.
The device is a surgical accessory used in dermatology procedures, not a device for performing tests on biological samples.
N/A
Intended Use / Indications for Use
Treating soft tissue on the skin with a laser requires a device that can manipulate and place the pulsed or CW emission by covering large and variable areas in a safe and consistent way. The LightScan provides the ability to cover small and large area of soft tissue on the skin while having control of the emission placement. The ability of the physician to identify the area to be treated by watching the aiming the shape and size that best fits the treated area will enhance the precision and safety of the timing of the emission placement on the skin is done by the LightScan hardware to avoid errors and to increase precision
Product codes
GEX
Device Description
Adding the LightScan to any laser will convert the system into an easy to use aesthetic surgery tool that can perform the widest range of cosmetic procedures. LightScan may be used for a variety of soft tissue ablation, vaporization and coagulation of soft tissue on the skin, including aesthetic laser surgery where layer by layer of micro-ablation is required. LightScan introduces an extra dimension of control for precise tissue removal using lower power than previously thought possible. The LightScan aiming beam makes visually displays the area about to be treated on the tissue. While watching the aiming beam, the physician can change the shapes and sizes he selects to use. The aiming beam outline will change in a concurrently to continuously display the area that is about to be treated.
Filling the area is done using a precise computer control motion that deflects the laser beam on the tissue to ensure maximum accuracy and homogeneity. Coordinating the laser emission is done by LightScan while leaving the physician in full control of laser emission at all times.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue on the skin
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)
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
Ka82295
AUG 6 1998
510 (k) Summary
| Name: Submitter: | Nidek Incorporated |
|---|---|
| Address: | 47651 Westinghouse Drive |
| Fremont, CA. 94539-7474 | |
| Phone Number: | (510) 226-5700, (800) 226-5750 |
| Fax Number: | (510) 226-5750 |
| Contact person: | Ken Kato |
| Date Prepared: | June 30, 1998 |
| Trade Name: | LightScan |
| Common Name: | Laser Accessory |
| Classification: | Class II |
Substantial Equivalence Claimed to: Sahar Technologies, Inc. SoftScan 510(k) Number K971024
Description:
Adding the LightScan to any laser will convert the system into an easy to use aesthetic surgery tool that can perform the widest range of cosmetic procedures. LightScan may be used for a variety of soft tissue ablation, vaporization and coagulation of soft tissue on the skin, including aesthetic laser surgery where layer by layer of micro-ablation is required. LightScan introduces an extra dimension of control for precise tissue removal using lower power than previously thought possible. The LightScan aiming beam makes visually displays the area about to be treated on the tissue. While watching the aiming beam, the physician can change the shapes and sizes he selects to use. The aiming beam outline will change in a concurrently to continuously display the area that is about to be treated.
Filling the area is done using a precise computer control motion that deflects the laser beam on the tissue to ensure maximum accuracy and homogeneity. Coordinating the laser emission is done by LightScan while leaving the physician in full control of laser emission at all times.
Intended Use:
Treating soft tissue on the skin with a laser requires a device that can manipulate and place the pulsed or CW emission by covering large and variable areas in a safe and consistent way. The LightScan provides the ability to cover small and large area of soft tissue on the skin while having control of the emission placement. The ability of the physician to identify the area to be treated by watching the aiming the shape and size that best fits the treated area will enhance the precision and safety of the timing of the emission placement on the skin is done by the LightScan hardware to avoid errors and to increase precision
1
and homogeneity. LightScan is a hand held device that is flexible enough to allow the freedom to choose the area of treatment without being restricted by the laser systems. LightScan will be sued to manipulate and place a pulsed and/or CW laser beam for use in dermatological applications including ablation, vaporization, and coagulation of soft tissue on the Skin.
Summary of the Technological Characteristics:
Technologically, the LightScan Scanning System offers all of the features and functionality of the Sahar Technologies SoftScan, Nidek CyberScan and LaserSonic's ParaScan, which all offer features and functionality in excess of the Coherent CPG. The LightScan offers a greater flexibility than the most others in terms of different wavelength specific applications.
Microprocessor controlled scanning systems in general bring improved safety to the laser applications due to the increased control, precise placement, and homogeneous application of laser energy.
Because of the normally tedious nature of applying single spot laser energy over large area, the LightScan improves safety by decreasing fatigue experienced by the physician during a procedure. The high bandwidth design of the LightScan system offers scanner capabilities previously unavailable in any applications other than CO2 laser soft tissue, extending the safety and effectiveness improvements to a broader range of procedures.
The improved performance of the LightScan device allows for better fluence at lower levels, which is also a net increase in safety.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUM SERVICES USA" is arranged around the eagle in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 6 1998
Mr. Ken Kato ·Nidek, Inc. 47651 Westinghouse Drive Fremont, California 94539-7474
Re: K982295 Trade Name: Nidek LightScan Regulatory Class: II Product Code: GEX Dated: June 30, 1998 Received: July 1, 1998
Dear Mr. Kato:
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 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.
3
Page 2 - Mr. Ken Kato
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,
Colin M. Witmer, Ph.D., M.D.
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
K99229 510(k) Number (if known):
Device Name: Nidek LightScan Device
Indications For Use: The LightScan accessory device is intended to be used to manipulate and place a pulsed and/or CW laser beam for use in Dermatology for treatment of any soft tissue, including, ablation, vaporization and coagulation of soft tissue on the skin.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) storative Devices Kg62225 Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109) (Optional Format 1-2-96)