(159 days)
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Not Found
No
The summary describes a topical pretreatment and does not mention any computational or algorithmic components related to AI/ML.
Yes
The device is described as a "topical pretreatment prior to undergoing laser hair removal" for certain hair types, which indicates it is used for medical treatment.
No
The device is described as a topical pretreatment for laser hair removal, not as a tool for diagnosing medical conditions or diseases.
No
The device is described as a "topical pretreatment" and an "Accessory to Surgical Laser Instruments," indicating it is a physical substance or product applied to the skin, not a software application.
Based on the provided information, Meladine™ Natural Melanin Enhancer is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of Meladine is a topical pretreatment applied to the skin prior to a laser procedure. It is not used to analyze blood, urine, tissue, or any other bodily fluid or sample.
- The device description clearly states it's an "Accessory to Surgical Laser Instruments used for Hair Removal." This further reinforces its role as a topical product used in conjunction with a medical procedure, not a diagnostic test.
Therefore, Meladine™ Natural Melanin Enhancer falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Meladine™ Natural Melanin Enhancer is indicated as a topical pretreatment prior to undergoing laser hair removal for patients suffering from unwanted, non-pigmented hair growth (white, grey, light blonde) who are unlikely to experience hair reduction with laser treatment alone.
Product codes
GEX
Device Description
Meladine™ Natural Melanin Enhancer (Accessory to Surgical Laser Instruments used for Hair Removal)
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
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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.
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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 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. Inside the circle is an abstract design featuring three curved lines above a stylized human profile, suggesting a connection between health, human services, and the United States.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 9 2003
Creative Technologies, Inc. c/o Elizabeth P. Noble 423 Bethel Drive Salisbury, North Carolina 28144
Re: K022807
Trade/Device Name: Meladine™ Natural Melanin Enhancer Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: November 11, 2002 Received: November 25, 2002
Dear Ms. Noble:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing
1
Page 2 - Ms. Elizabeth P. Noble
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C Provost
For 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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Page 1 of 1
510(k) Number (if known): K022807
Mcladine™ Natural Melanin Enhancer Device Namc:
(Accessory to Surgical Laser Instruments used for Hair Removal)
Indications for Use:
Meladine™ Natural Melanin Enhancer is indicated as a topical pretreatment prior to undergoing laser hair removal for patients sullering from unwanted, non-pigmented hair growth (white, grey, light blonde) who are unlikely to experience hair reduction with laser reatment alone.
(PI.F.A.SF. DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Ollice of Device Evaluation (ODE)
Miriam C. Provost
ivision of General, Restorative ad Neurological Devices
KO 22807
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