(39 days)
Indications for use for Fitzpatrick skin types (I to V).
The Chromolite™ EP System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostatis of soft tissue in the medical specialities of plastic surgery and dermatology as follows:-
Indications for use for Fitzpatrick skin types (I to V).
- . The treatment of moderate inflammatory acne vulgaris
- The treatment of benign pigmented epidermal lesions including dyschromia, hyper-. pigmentation, melasma, ephelides (freckles)
- . The treatment of cutaneous lesions including warts,scars, and striae.
- . The treatment of benign cutaneous vascular lesioins, including port wine stains, hemamangiomas, facial, truncal, and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
- . The removal of unwanted hair and to effect stable long-term or permanent hair reduction.
1 = Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
The Chromolite™ EP System is an Intense Pulsed Light-based medical device utilising xenon flashlamp technology to illuminate, to offer light based therapies as listed in the indications for use. The Chromolite" " EP System emits light at 390nm to 1200nm via a 50mm x 15mm waveguide at a repetition rate of up to 0.5Hz.
The provided text is a 510(k) summary for the Chromolite™ EP System, an Intense Pulsed Light (IPL) device. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information about acceptance criteria, a study proving device performance against such criteria, sample sizes, expert involvement, ground truth establishment, or specific performance metrics.
The document states that the Chromolite™ EP System is a hardware and software modification of a previously cleared device (Chomolite™ System) and that both have the same intended use and operating principle. The FDA's letter confirms substantial equivalence to a legally marketed predicate device. This implies that the device's safety and effectiveness are established by demonstrating it is as safe and effective as a device already on the market, rather than through a new, independent performance study meeting specific acceptance criteria that would typically be described for a novel device or a device claiming a new indication.
Therefore, I cannot fulfill your request for:
- Table of acceptance criteria and reported device performance: This information is not present. The document focuses on demonstrating substantial equivalence to a predicate device.
- Sample sizes, data provenance: Not mentioned.
- Number of experts and qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned and likely not applicable for a substantial equivalence claim based on modifications to an existing IPL device.
- Standalone performance: Not mentioned. The device's performance is implicitly linked to the predicate device it is substantially equivalent to.
- Type of ground truth: Not mentioned.
- Training set sample size: Not mentioned.
- How ground truth for training set was established: Not mentioned.
The 510(k) summary provided is focused on regulatory clearance through substantial equivalence, not on detailing a performance study with specific acceptance criteria and results.
{0}------------------------------------------------
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K081619
Submitter: A.
Chromogenex Technologies Limited Units 1-2 Heol Rhosyn Parc Dafen Llanelli Carmarthenshire Great Britain
Phone: +44 (0) 1554 755444 +44 (0) 1554 755333 Fax:
Contact: Mr Peter R Bevan (Quality Manager)
Date Prepared: 30th April 2008
B. Device Names:
| Classification name | Laser Surgical Instrument 21 C.F.R 878.4810 |
|---|---|
| Common/usual name | Chromolite - Intense Pulsed Light (IPL) |
| Proprietary name | ChromoliteTM EP |
Chromolite™ System C. Predicate Device:
Device Description: D.
The Chromolite™ EP System is an Intense Pulsed Light-based medical device utilising xenon flashlamp technology to illuminate, to offer light based therapies as listed in the indications for use. The Chromolite" " EP System emits light at 390nm to 1200nm via a 50mm x 15mm waveguide at a repetition rate of up to 0.5Hz.
Intended Use: E.
Indications for use for Fitzpatrick skin types (I to V).
The Chromolite™ EP System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostatis of soft tissue in the medical specialities of plastic surgery and dermatology as follows:-
{1}------------------------------------------------
Special 510(k): Device Modification Chromolite™ EP
Indications for use for Fitzpatrick skin types (I to V).
- The treatment of moderate inflammatory acne vulgaris .
- The treatment of benign pigmented epidermal lesions including dyschromia, hyper-. pigmentation, melasma, ephelides (freckles)
- The treatment of cutancous lesions including warts,scars, and striae. .
- The treatment of benign cutaneous vascular lesioins, including port wine stains, . hemamangiomas, facial, truncal, and leg telangicctasias,erythema of rosacea,angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
- The removal of unwanted hair and to effect stable long-term or permanent hair reduction. .
1 = Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
Comparison with the Predicate Device: F.
The Chromolite™ EP System is a hardware and software modification of the previously cleared Chomolite™ System. The Chromolite™ EP and the Chomolite™ System have the same intended use and use the same operating principle.
Based on the data and information presented here, the Chromolite™ EP System is substantially equivalent to the Chomolite™ System currently manufactured and distributed by Chromogenex Technologies Limited.
{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 stylized caduceus, which is a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Chromogenex Technologies Limited % Mr. Peter R. Bevan Quality Manager Units 1-2 Heol Rhosyn Parc Dafen Ind. Est. Llanelli Carmarthenshire SA14 8QG Great Britain
JUL 1 8 2008
Re: K081619
Trade/Device Name: Chromolite™ EP 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: May 23, 2008 Received: July 7, 2008
Dear Mr. Bevan:
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
{3}------------------------------------------------
Page 2 - Mr. Peter R. Bevan
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.
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 Compliance 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 Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems 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 address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Mark N. Mulhern
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Special 510(k): Device Modification Chromolite™ EP
Indications for Use
510(k) Number (if known): K081619
Device Name: _ Chromolite™ EP System _________________________________________________________________________________________________________________________________________
Indications for use for Fitzpatrick skin types (I to V).
The Chromolite™ EP System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostatis of soft tissue in the medical specialities of plastic surgery and dermatology as follows:-
Indications for use for Fitzpatrick skin types (I to V).
- . The treatment of moderate inflammatory acne vulgaris
- The treatment of benign pigmented epidermal lesions including dyschromia, hyper-. pigmentation, melasma, ephelides (freckles)
- . The treatment of cutaneous lesions including warts,scars, and striae.
- . The treatment of benign cutaneous vascular lesioins, including port wine stains, hemamangiomas, facial, truncal, and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
- . The removal of unwanted hair and to effect stable long-term or permanent hair reduction.
1 = Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ Subpart D)
Over-The-Counter Use ______ (21 CFR 801 AND/OR (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Division of General, Restorative, and Neurological Devi
510(k) Number L041614
§ 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.