(61 days)
Not Found
No
The document describes a pulsed Xenon flashlamp system with no mention of AI or ML technology in its description, intended use, or performance studies.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use in Dermatological and Plastic Surgery applications and specifically for long term stable, or permanent, hair reduction" and "for the treatment of benign cutaneous vascular lesions" and "benign pigmented lesions," which are therapeutic applications.
No
The device is indicated for treatment (hair reduction, vascular lesions, pigmented lesions), not for diagnosing conditions.
No
The device description explicitly details hardware components including a base unit, umbilical interconnection, and a handpiece housing a xenon light source, filter, and finger switch. This indicates it is a hardware-based medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The IFL Professional System is a light-based system that delivers energy directly to the patient's skin for therapeutic purposes (hair reduction, treatment of vascular and pigmented lesions). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly describes treatments applied to the patient's body, not diagnostic testing of samples.
Therefore, based on the provided information, the IFL Professional System is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IFL Professional System is indicated for use in Dermatological and Plastic Surgery applications and specifically for long term stable, or permanent, hair reduction.
In addition, the IFL Professional System is indicated for the treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations: and the treatment of benign pigmented lesions.
Product codes
GEX
Device Description
The IFL Professional System is a pulsed Xenon flashlamp delivering energy in the 530 to 1200nm wavelength range. The system consists of a base unit containing the electrical and electronic control subsystems, an umbilical interconnection between the base unit and the handpiece, and the handpiece which houses the xenon light source, filter and finger switch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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)
Not Found
§ 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.
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K040156 1 of 2
510(k) Submission IFL Professional System MAR 2 4 2004
Section 12 510(k) Summary Statement Cyden Limited IFL Professional System
1. General Information
- Submitter: Cyden Ltd Technium Kings Road, The Docks Swansea, Wales, UK, SA1 8PH
Dr Mike Kiernan - Technical Director Contact Person:
14th January 2004 Summary Preparation Date:
2. Names
IFL Professional System Device Name:
Laser Powered Surgical Instrument Primary Classification Name:
3. Predicate Devices
- Palomar Estelux System, cleared May 2002, 510(k) approval . number K020453:
- Lumenis Vasculite System, cleared July 2003, 510(k) approval . number K030342.
4. Product Description
The IFL Professional System is a pulsed Xenon flashlamp delivering energy in the 530 to 1200nm wavelength range. The system consists of a base unit containing the electrical and electronic control subsystems, an umbilical interconnection between the base unit and the handpiece, and the handpiece which houses the xenon light source, filter and finger switch.
5. Indications for Use
The IFL Professional System is indicated for use in Dermatological and Plastic Surgery applications and specifically for long term stable, or permanent, hair reduction.
In addition, the IFL Professional System is indicated for the treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations: and the treatment of benign pigmented lesions.
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K040156 2 of 2
510(k) Submission IFL Professional System
6. Rationale for Substantial Equivalence
The IFL Professional system and its predicate devices have as a come technological characteristics, i.e. pulsed light output in the 530-1200nm wavelength range produced via electrical excitation of xenon flashlamps. The wavolonger for Use of the IFL Professional and the predicate devices are identical, namely long term stable, or permanent, hair reduction and the treatment of benign pigmented and vascular lesions.
7. Safety and Efficacy Information
Not Applicable. Substantial equivalence to the predicate devices is claimed rtor identical technological characteristics and intended Indications for Use.
8. Conclusion
The IFL Professional system has been found to be substantially equivalent to the predicate devices, specifically in technological design and operation and similar in nature to the desired physiological interactions. The design and manufacture of the device is in accordance with the relative international standards and the potential risk to operator and patient has been minimized.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle emblem with three parallel lines forming the body and wings.
MAR 2 4 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Public Health Service
Dr. Michael N. Kiernan Technical Director Cyden Limited Technium Kings Road, The Docks Swansea Wales, UK, SA1 8PH
Re: K040156
Trade/Device Name: IFL Professional 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 14, 2004 Received: January 23, 2004
Dear Dr. Kiernan:
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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adultcration.
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 cquivalence 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); 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.
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Page 2 - Dr. Michael N. Kiernan
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). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
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
4
Indications for Use
510(k) Number (if known): K040156
Device Name: IFL Professional System
Indications For Use:
The IFL Professional System is indicated for use in Dermatological and Plastic Surgery applications and specifically for long term stable, or permanent, hair reduction.
In addition, the IFL Professional System is indicated for the treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; and the treatment of benign pigmented lesions.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
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510(k) Number_Ko40156