(234 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, or related concepts, and the intended use describes a laser device for tattoo removal and pigmented lesion treatment, which are typically hardware-driven procedures.
Yes
The device is intended for the "treatment of benign superficial pigmented skin lesions," which is a therapeutic application. The lightening of tattoos can also be considered a therapeutic, albeit cosmetic, treatment.
No
Explanation: The Intended Use/Indications for Use section describes the device's function as a treatment device for lightening tattoos and treating benign pigmented skin lesions, not for diagnosis.
No
The provided 510(k) summary is incomplete and lacks a device description. The intended use describes a device that uses "Q-SWITCHED MODE" and "LONG-PULSE MODE" for treating skin conditions, which strongly suggests a hardware-based laser or light therapy device, 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 describes the device as being used for lightening tattoos and treating benign superficial pigmented skin lesions. These are procedures performed directly on the patient's skin, not on samples taken from the body (like blood, urine, or tissue).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing information about a patient's health status based on sample analysis.
- Using reagents or assays.
Therefore, this device appears to be a therapeutic or aesthetic device used for skin treatments, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Q-SWITCHED MODE: FOR LIGHTENING OF TATTOOS (BLACK, YELLOW, AND BLUE INKS).
LONG-PULSE MODE: FOR TREATMENT OF BENIGN SUPERFICIAL PIGMENTED SKIN LESIONS --LENTIGINES -- CAFE-AU-LAIT -- - - - - - --- EPHELDES never of OR -
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
SKIN
Indicated Patient Age Range
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Intended User / Care Setting
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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).
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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 design of three curved shapes that resemble a person embracing another person. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
David K. Quon, M.D. . President American Lasers, Inc. 300 East Main Street Alhambra, California 91801
SEP 2 9 1997
K970475 Re: Trade Name: MM-RUBY Regulatory Class: II Product Code: GEX Dated: August 30, 1997 Received: September 4, 1997
Dear Dr. Quon:
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 (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.
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Page 2 - David K. Quon, M.D.
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 vour 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
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Page 1 of 1__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): K970475
Device Name: MM-RUBY
Indications For Use:
Q-SWITCHED MODE: FOR LIGHTENING OF TATTOOS (BLACK, YELLOW, AND BLUE INKS).
LONG-PULSE MODE: FOR TREATMENT OF BENIGN SUPERFICIAL PIGMENTED SKIN LESIONS --LENTIGINES -- CAFE-AU-LAIT -- - - - - - --- EPHELDES never of OR -
(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 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
bccellz
(Division Sign-Off)
Division of General Restorative Devices K970475
510(k) Number
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