(86 days)
Not Found
Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML.
No
The "Intended Use / Indications for Use" describes a "LIGHTENING RED I-xcEPT R TONIC" for "FRIDERMAL PIGATENTED" issues and "NEVUS". While it addresses a skin condition (pigmentation, nevus), the described product (tonic) suggests a cosmetic or topical application for lightening, rather than a medical therapy. Without further information about its mechanism of action or claims of treating a disease, it cannot be definitively classified as a therapeutic device.
No
The Intended Use / Indications for Use describe a cosmetic treatment for pigmented lesions or nevi, not a diagnostic process.
Unknown
The provided text is incomplete and lacks a device description, making it impossible to determine if the device is software-only.
Based on the provided information, it is highly unlikely that this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use mentions "LIGHTENING RED I-xcEPT R TONIC 7-0 R JRZATMENT 1 151 FRIDERMAL PIGATENTED 0 L o 7 A NEVUS of FOR RZATMITENT (". While the text is somewhat garbled, it strongly suggests a topical treatment or cosmetic product intended for external application to the skin, likely related to pigmentation or nevi (moles). IVDs are used to examine specimens from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Lack of IVD Characteristics: The description doesn't mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information.
- Using reagents or laboratory procedures.
- Being used in a laboratory or clinical setting for testing specimens.
In summary, the intended use points towards a topical treatment, not a diagnostic test performed on biological samples.
Therefore, based on the available information, this device does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
ALL 7A7700 FOR 02 (D) LIGHTENING RED I-xcEPT R TONIC 7-0 R JRZATMENT 1 151 FRIDERMAL PIGATENTED 0 L o 7 A NEVUS of FOR RZATMITENT (
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
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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
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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.)
Not Found
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.
Not Found
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 shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle-like symbol with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. The seal is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 28 1998
David K. Ouon. MD. President American Lasers, Incorporated 300 East Main Street Alhambra, California 91801
K974142 Re:
Trade Name: HM-Ruby Regulatory Class: II Product Code: GEX Dated: November 1, 1997 Received: November 3, 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 (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
1
Page 2 - Dr. Quon
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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,
Cla atta
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
2
P01
| Page | of | |
|---|---|---|
| ------ | ---- | -- |
K 97 4142 510(k) Number (if known): KU B l)evice Name:_ Indications For Use:
ALL 7A7700 FOR 02 (D) LIGHTENING RED I-xcEPT
R TONIC 7-0 R JRZATMENT 1 151 FRIDERMAL PIGATENTED
0 L o 7 A NEVUS of FOR RZATMITENT (
(PLEASE DO NOT WRITE BELOW THIS-LINE - CONTINUE ON ANOTHER PAGE IF NEEDDED)
Concurrence of CDRH, Office of Device Evaluation (ONF)
(Division Sign-Off)
Division of General Restorative Devices..
510(k) Number K974142
OR
Prescription Use (Per 21 CFR 801.109)
Over-Tle-Countor Use
(Optional Format 1-2-96)