(63 days)
The IPL HAIR REMOVAL Device (Model: TFDA06S-A ) is an over-the-counter device indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
Not Found
The provided FDA 510(k) clearance letter and associated Indications for Use document for the "IPL Hair Removal" device (K220927) do not contain detailed information regarding acceptance criteria, specific study designs, or performance metrics from clinical trials.
FDA 510(k) clearances typically establish substantial equivalence to a predicate device, which means the new device is as safe and effective as a legally marketed device. While a 510(k) submission includes documentation of performance testing, the public clearance letter usually summarizes the outcome rather than providing the granular data often found in premarket approval (PMA) applications or detailed clinical study reports.
Therefore, I cannot extract the specific information requested in your prompt (Table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types for test/training sets, and training set size).
The document states:
- Device Name: IPL HAIR REMOVAL (Model: TFDA06S-A)
- Indications for Use: Over-the-counter device for the removal of unwanted hair and permanent reduction in hair regrowth (defined as long-term, stable reduction measured at 6, 9, and 12 months after treatment regime completion) for adults.
- Regulatory Class: Class II
To obtain the detailed information you are requesting about specific acceptance criteria and study data, one would typically need to:
- Access the full 510(k) Summary: While not included in this document, a 510(k) Summary often contains more details about the performance data presented to the FDA. These are publicly available through the FDA's 510(k) database.
- Review the actual 510(k) submission: This document (which is usually proprietary and not publicly available in its entirety) would contain the complete study protocols, raw data, statistical analyses, and reports.
- Consult relevant publications or manufacturer's technical documentation: If the device manufacturer has published clinical data or provided more detailed technical specifications, that information would be found outside of the FDA clearance letter.
In summary, based only on the provided text, none of the specific study details you've asked for (acceptance criteria table, sample sizes, expert details, adjudication, MRMC, standalone, ground truth info) are present. The document confirms the device's clearance based on substantial equivalence for the stated indications.
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June 2, 2022
Shenzhen Qiaochengli Technology Co., Ltd. Guoming Zhou Official Correspondent 501-5, rujun building, 105 Zhongxing Road, Ma'antang community, Bantian street, Longgang District Shenzhen, Guangdong China
Re: K220927
Trade/Device Name: IPL Hair Removal Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: Class II Product Code: OHT Dated: March 28, 2022 Received: March 31, 2022
Dear Guoming Zhou:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K220927
Device Name IPL HAIR REMOVAL
Indications for Use (Describe)
The IPL HAIR REMOVAL Device (Model: TFDA06S-A ) is an over-the-counter device indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
Type of Use (Select one or both, as applicable):
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.