(35 days)
The Chromolite™ System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialities of plastic surgery and dermatology as follows:
- 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 lesions, . including port wine stains, hemangiomas, facial, truncal and leq 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.
The Chromolite™ is a Intense Pulsed Light-based medical device utilising xenon flashlamp technology to illuminate the dermis to offer light based therapies as listed in the indications of use. The Chromolite™ emits light at 390nm to 1200nm via a 50mm x 15mm waveguide at a repetition rate of 0.5Hz.
The provided text is a 510(k) summary for the Chromolite™ System, an Intense Pulsed Light (IPL) device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies with specific acceptance criteria as might be seen for novel devices. Therefore, much of the requested information regarding detailed acceptance criteria and study designs is not present in this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria (e.g., specific percentages for improvement, reduction, or clearance) nor does it present a table of reported device performance metrics against such criteria. The 510(k) process primarily relies on demonstrating that the new device is as safe and effective as a predicate device through comparison of technological characteristics, intended use, and indications for use.
The "Performance Standards" section notes that the device complies with the European Medical Directive 93/42/EEC and will comply with voluntary standards UL60601-1:1996 for safety when marketed in the U.S. These are general safety and electrical standards, not performance criteria related to the clinical efficacy of the treatments.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" in the context of a clinical study with a defined sample size. The 510(k) summary is a regulatory submission, not a study report. It focuses on comparison to a predicate device and outlining general indications for use supported by the underlying technology (IPL).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
There is no mention of a test set with ground truth established by experts.
4. Adjudication Method for the Test Set
Not applicable, as no such test set or adjudication process is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study and Effect Size
No MRMC comparative effectiveness study is mentioned. This device is an IPL system for various dermatological and cosmetic treatments, not a diagnostic imaging device where MRMC studies are typically conducted.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This is an IPL device operated by a human. There is no "algorithm only" or "AI" component described in this document for standalone performance evaluation.
7. Type of Ground Truth Used
Not applicable, as no specific clinical study data requiring ground truth is detailed in this 510(k) summary for the purpose of demonstrating efficacy beyond equivalence to a predicate device.
8. Sample Size for the Training Set
Not applicable. The document does not describe a training set in the context of an AI/ML model.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as per 510(k) process):
The provided document does not describe a specific clinical study with quantitative acceptance criteria and a detailed report of results against those criteria. Instead, it is a 510(k) Premarket Notification submission.
The "study" in this context is the company's demonstration that the Chromolite™ System is substantially equivalent to a legally marketed predicate device, the Orion lasers, Lovely system II (Harmony) (K033946).
The basis for proving this "acceptance" (i.e., substantial equivalence) is through:
- Comparison of Indications for Use: The Chromolite™ System shares the same or very similar aesthetic and cosmetic applications requiring selective photothermolysis, photocoagulation, or coagulation, and hemostasis of soft tissue as the predicate. The listed indications include treatment of:
- Moderate inflammatory acne vulgaris
- Benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, freckles)
- Cutaneous lesions (warts, scars, striae)
- Benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea erythema, angiomas, spider angiomas, poikiloderma of civatte, leg veins, venous malformations)
- Unwanted hair removal and stable long-term or permanent hair reduction.
- Comparison of Technological Characteristics: The predatory device is also an Intense Pulsed Light (IPL) system. The Chromolite™ System utilizes xenon flashlamp technology, emits light at 390nm to 1200nm, via a 50mm x 15mm waveguide at a repetition rate of 0.5Hz. The document implies these characteristics are sufficiently similar to the predicate to establish equivalence regarding safety and effectiveness for the stated indications.
- Compliance with Safety Standards: The device states compliance with the European Medical Directive 93/42/EEC and voluntary safety standard UL60601-1:1996.
The conclusion of the 510(k) summary states: "The Chromolite system is substantially equivalent to its predicate device cited above, and raises no new safety and/or efficacy issues." The FDA's letter (K053324) confirms this substantial equivalence determination, allowing the device to be marketed.
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| 510(k) Summary of Safety and Effectiveness | |
|---|---|
| Chromolite™ System | |
| 510(k) Number K 053324 | |
| Applicant: | Chromogenex Plc. |
| Address: | Units 1 & 2 Heol RhosynParc DafenLlanelliCarmarthenshireS. WalesSA14 8QGUK |
| Contact Person: | Mr. Chris Williams, Product Development Director |
| Telephone: | +44 (0) 1554 755444 |
| Fax: | +44 (0) 1554 755333 |
| Date prepared: | July 2005 |
| Device Trade Name: | Chromolite™ System |
| Common Name: | Intense Pulsed Light (IPL) |
| Classification Name: | Laser Surgical Instrument 21 C.F.R § 878.4810. |
| Product Classification: | Class II device. |
| Product Code: | GEX |
| Legally Marketed Predicate Device: | The Chromolite™ System is substantially equivalent in terms oftechnological characteristics, performance, intended use,indications for use and operator interface to;• Orion lasers, Lovely system II (Harmony) (K033946) |
| System Description: | The Chromolite™ is a Intense Pulsed Light-based medical deviceutilising xenon flashlamp technology to illuminate the dermis tooffer light based therapies as listed in the indications of use. TheChromolite™ emits light at 390nm to 1200nm via a 50mm x 15mmwaveguide at a repetition rate of 0.5Hz. |
| Performance Standards: | The device complies with the European Medical Directive93/42/EEC concerning medical devices, and will comply withvoluntary standards UL60601-1:1996 when marketed in the U.S. |
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K0 53324 2/2
- Indications for use: The Chromolite™ System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialities of plastic surgery and dermatology as follows:
- 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 lesions, . including port wine stains, hemangiomas, facial, truncal and leq 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 reqimen.
- Conclusion: The Chromolite system is substantially equivalent to its predicate device cited above, and raises no new safety and/or efficacy issues.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features an abstract eagle design with three stylized lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle, indicating the department's name and country.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2006 JAN 5
Chromogenex Plc c/o Marc M. Mouser Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, Washington 98607
Re: K053324
Trade/Device Name: Chromolite System Regulation Number: 21 CFR 878.4810 Regulation Name: 21 CFX 078-1010
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 21, 2005 Received: December 22, 2005
Dear Mr. Mouser:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section >10(x) prematice names in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regard mannent date of the Medical Device Amendments, or to commerce prior to May 20, 1976, the encentance with the provisions of the Federal Food. Drug. devices that have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not requent appro to the general controls provisions of the Act. The 1 ou may, dicierole, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 IT your device is classified (see above) the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations with may be subject to sach additions. Title 21, Parts 800 to 898. In addition. FDA may oublish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease be advised that I Dri 3 losaanse over device complies with other requirements of the Act that 117A has made a determinations administered by other Federal agencies. You must of any it cachar statutes and regulations and limited to: registration and listing (21 comply with an the Fer 816 creations)
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI It I art 607), laboring (27 OFF regulation (21 CFR Part 820); and if applicable, the electronic torth in the quanty systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Marc M. Mouser
This letter will allow you to begin marketing your device as described in your Section 510(k) This iciter will anow you'ls ough mating of substantial equivalence of your device to a legally prematics notification: 11.0 12.01.2017 11:20:53 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 If you desire specific advice for Jour as 101) 276-0115. Also, please note the regulation entitled, comater the Oriece of Companise notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general 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/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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chror
Indications for Use
510(k) Number (if known):
Device Name: Chromolite system
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, . hyperpigmentation, melasma, ephelides (freckles)
- The treatment of cutaneous lesions including warts, scars, and striae. .
- The treatment of benign cutaneous vascular lesions, including port wine stains, . hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, nomangiomas, 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(Part 21 CFR 801 Subpart D) | x |
|---|---|
| AND/OR | |
| Over-The-Counter Use(21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE
Page 1 of
(Division Sign-Of Division of General, Restorative, and Neurological De
510(k) Number K053324
§ 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.