(184 days)
Not Found
No
The device description focuses on the physical components and optical principles of a laser system, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is used for medical procedures like incision, excision, ablation, and tattoo removal, which are therapeutic interventions.
No
The device description focuses on therapeutic applications like "incision, excision, ablation, vaporization of soft tissue," and "tattoo removal." There is no mention of any diagnostic function or ability to identify medical conditions.
No
The device description clearly outlines multiple hardware components including a power supply, water cooling system, optical bench with a YAG rod, flashlamp, mirrors, frequency doubler crystal, and articulated arm. This is a hardware-based laser system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for surgical procedures on soft tissue (incision, excision, ablation, vaporization) and cosmetic/dermatological treatments (tattoo removal, vascular and pigmented lesions). These are all procedures performed on the patient's body, not on samples taken from the body.
- Device Description: The description details a laser system designed to deliver energy to tissue. This is consistent with a surgical or dermatological device, not a device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
For incision, excision, ablation, vaporization of soft tissue for general dermatology, as well as at the 1064nm wavelength, dark ink (blue/black) tattoo removal and Nevus of Ota and at the 532nm wavelength, light ink (red) tattoo removal, vascular and pigmented lesions.
Product codes
GEX
Device Description
Medlite IVTM consists of three main components: the power supply used to provide the proper voltage and current to the laser system, the water cooling system used to remove heat from the power supply and the optical bench consisting of the YAG rod, flashlamp, various mirrors, frequency doubler crystal and articulated arm.
The lasing action of the Medlite IVTM occurs when first the flashlamp is excited by a high voltage electrical pulse from the power supply. The excited flashlamp then emits an intense broad-spectrum light. The YAG rod absorbs most of this light and then releases the energy as laser light at 1064nm.
The Q-Switch acts as an extremely high speed shutter and can be set to release the light at pulse rates of 1, 2, 5, and 10 pulses per second or single shot. The frequency doubler can be enabled to change the 1064nm (infrared) light to a second wavelength at 532nm (green).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
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)
Nonclinical Performance Data: None presented at this time.
Clinical Performance Data: None presented at this time.
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
:
510(k) Summary
| Submitter: | Continuum Biomedical
A Medical Division of Continuum Electro-Optics, Inc.
6533 Sierra Lane
Dublin, CA 94568
phone: (510) 828-3210
fax: (510) 556-2222 |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Laurie A. Ridener
Regulatory Affairs Officer |
| Date Summary Prepared: | August 1, 1997 |
| Device Trade Name: | Medlite IVTM Q-Switched Nd:YAG Laser System |
| Common Name: | Medical laser system |
| Classification Name: | Instrument, surgical, powered, laser
79-GEX
21 CRF 878.48 |
| Equivalent Device: | Polytec PI LaseAway Nd:YAG Laser (Lambda Photometrics, Ltd.)
(K942622) |
| Device Description: | Medlite IVTM consists of three main components: the power supply used
to provide the proper voltage and current to the laser system, the water
cooling system used to remove heat from the power supply and the
optical bench consisting of the YAG rod, flashlamp, various mirrors,
frequency doubler crystal and articulated arm.
The lasing action of the Medlite IVTM occurs when first the flashlamp is
excited by a high voltage electrical pulse from the power supply. The
excited flashlamp then emits an intense broad-spectrum light. The YAG
rod absorbs most of this light and then releases the energy as laser light
at 1064nm.
The Q-Switch acts as an extremely high speed shutter and can be set to
release the light at pulse rates of 1, 2, 5, and 10 pulses per second or
single shot. The frequency doubler can be enabled to change the
1064nm (infrared) light to a second wavelength at 532nm (green). |
PROPRIETARY DATA: This document and information contained herein may not be reproduced, used or disclosed without written permission of Continuum Biomedical, A Medical Division of Continuum Electro-Optics, Inc.
ပါ မြ
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510(k) Summary (cont'd)
・・・
For incision, excision, ablation, vaporization of soft tissue for general Intended Use: dermatology, as well as at the 1064nm wavelength, dark ink (blue/black) tattoo removal and Nevus of Ota and at the 532nm wavelength, light ink (red) tattoo removal, vascular and pigmented lesions. Medlite IV™ Q-Switched Nd:YAG Laser and the Polytec PI Comparison: LaseAway Nd:YAG Laser (Lambda Photometrics, Ltd.) are equivalent in operating parameters, physical characteristics and intended uses.
None presented at this time. Nonclinical Performance Data:
None presented at this time. Clinical Performance Data:
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Laurie A. Ridener Regulatory Affairs Officer Continuum Biomedical, Inc. .. 6533 Sierra Lane Dublin, California 94568
SEP - 5 1997
Re: K970808
Trade Name: Medlite IV™ O-Switched Nd: YAG Laser System Regulatory Class: II Product Code: GEX Dated: June 13, 1997 Received: June 16, 1997
Dear Ms. Ridener:
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 requirements , as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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. Laurie A. Ridener
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,
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
: :
| 510(k) Number (if known): | K970808 |
|---|---|
| Device Name: | Medlite IV™ Q-Switched Nd:YAG Laser System |
| Indication for Use: | For incision, excision, ablation, vaporization in soft tissue |
| for general dermatology |
Specific Indications:
· 11 ·
1064nm wavelength:
Dark ink (blue, black) tattoo removal Nevus of Ota
532nm wavelength:
Light ink (red) tattoo removal Vascular lesions Epidermal pigmented lesions
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General Restorative Devices | |
| 510(k) Number | K970802 |
| Prescription Use
| (Per 21 CFR 801.109) | OR | Over-the-Counter Use |
|---|---|---|
| ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)
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