(183 days)
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No
The summary does not mention any AI or ML terms, image processing, or performance studies typically associated with AI/ML devices. The device description and intended use are consistent with a traditional laser device.
Yes
The device is intended for medical applications, specifically hair removal, coagulation of vascular lesions, and vaporization, ablation, incision, and excision of soft tissue, which directly relate to the treatment of a condition or provide therapy.
No
Explanation: The Uni-Laser™ 430 is intended for therapeutic applications like hair removal, coagulation, vaporization, ablation, incision, and excision of soft tissue, not for diagnosing conditions.
No
The device description explicitly states "Uni-Laser™ 430", which is a laser system, a hardware device. The intended use also describes procedures performed by a laser.
Based on the provided information, the Uni-Laser™ 430 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- Uni-Laser™ 430 Intended Use: The intended use of the Uni-Laser™ 430 is for procedures performed directly on the human body (in vivo), such as hair removal and soft tissue applications like coagulation, vaporization, ablation, incision, and excision.
Therefore, the Uni-Laser™ 430 is a therapeutic device used for medical procedures performed on the patient, not for testing samples taken from the patient.
N/A
Intended Use / Indications for Use
The Uni-Laser™ 430 is intended for use in hair removal (destruction of hair follicles) in skin types I-IV, and for soft tissue applications, such as coagulation of soft tissue, e.g., vascular lesions (visible blood vessels)
In contact mode the Uni-Laser 430 can be used for vaporization, ablation, incision, and excision of soft tissue.
Product codes
GEX
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
physician or other practitioner licensed by state law to use or order the use of this device.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and head. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it. The text is written in a sans-serif font and is evenly spaced around the circle.
MAY 1 1 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Jan K. Enemaerke President MedArt Corporation 11772 Sorrento Valley Road, Suite 240 San Diego, California 92121
Re: K993815 Trade Name: MedArt Corporation Uni-Laser™ 430 Regulatory Class: II Product Code: GEX Dated: February 7, 2000 Received: February 11, 2000
Dear Mr. Enemaerke:
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 (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.
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Page 2 - Mr. Jan K. Enemaerke
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,
Durna R. Lochner.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 7
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: MedArt Corporation Uni-Laser™ 430
Indications for Use Statement:
The Uni-Laser™ 430 is intended for use in hair removal (destruction of hair follicles) in skin types I-IV, and for soft tissue applications, such as coagulation of soft tissue, e.g., vascular lesions (visible blood vessels)
In contact mode the Uni-Laser 430 can be used for vaporization, ablation, incision, and excision of soft tissue.
CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician or other practitioner licensed by state law to use or order the use of this device.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use _ (Per 21 CFR 801.109)
OR
510(k) Number
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
Duane R. Klines
(Division Sign-Off)
vision of General Restorative Devices
rev 2/2000