(47 days)
The iPulse i150 System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology. The iPulse i150 system emits a wavelength of 530nm to 1200nm and is specifically intended for the long term stable, or permanent, reduction in hair.
Not Found
The provided text is a 510(k) clearance letter from the FDA for the "IPL iPulse i150 System" and indicates that the device is substantially equivalent to legally marketed predicate devices. This type of document does not typically contain detailed information about specific acceptance criteria and the results of a study demonstrating fulfillment of those criteria as it is primarily a regulatory clearance based on substantial equivalence.
The information requested in your prompt (e.g., specific acceptance criteria, detailed study results, sample sizes, ground truth establishment, expert qualifications, etc.) are usually found in the original 510(k) submission document itself, which is not included here. This letter only confirms that the FDA reviewed the submission and found the device substantially equivalent.
Therefore,Based on the provided document, I cannot fulfill your request for the following reasons:
- No acceptance criteria or device performance data is stated: The document is an FDA clearance letter based on substantial equivalence, not a summary of performance study results against specific criteria.
- No study details are provided: The letter does not describe any specific study conducted to prove the device meets acceptance criteria.
- Specifics of the requested details are absent: All points listed in your request (sample sizes, data provenance, expert details, adjudication, MRMC study, standalone performance, ground truth types, training set details) are not present in this regulatory clearance letter.
To obtain the information you're looking for, you would typically need to refer to the original 510(k) submission document from the manufacturer or publicly available summaries of those submissions that may include clinical or performance data.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cyden Limited % Dr. Michael Kiernan Technium, Kings Road The Docks, Swansea, Wales SA1 8PH United Kingdom
Re: K083748
Trade/Device Name: IPL iPulse i150 System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 22, 2009
- 2 2009
Dear Dr. Kiernan:
Received: January 26, 2009
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, insting 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, TDA max 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 manion over not 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); good manufacturing practice requirements as set
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Page 2 - Dr. Michael Kiernan
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 Center for Devices and Radiological Health's (CDRH's) Office of Crampliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Pestmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Syrcems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet adHress. http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Mulkerson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): K083748
Device Name: IPL iPulse i150 System
Indications For Use:
The iPulse i150 System is a laser surgical instrument for use in General and Plastic Surgery and Dermatology.
The iPulse i150 system emits a wavelength of 530nm to 1200nm and is specifically intended for the long term stable, or permanent, reduction in hair.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Ove r-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Ex off Off
Division of General, Restorative, and Neurological Devices
510 (k) Number 1-of
§ 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.