(60 days)
The 500 – 1200nm intense pulsed light wavelengths are indicated for:
- The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles)
- The treatment of cutaneous lesions, including warts, scars and striae
The 560 – 1200nm intense pulsed light wavelengths are indicated for: - The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
The 600 - 1200nm intense pulsed light wavelengths are indicated for: - The removal of unwanted hair from all skin types and to effect stable, long-term or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The 400 - 1200nm intense pulsed light wavelengths are indicated for: - The treatment of moderate inflammatory acne vulgaris.
The Fusion System consists of:
The main console unit that incorporates the touch-screen control panel, power supply module, cooling system, switching module and isolation transformer
Variety of handpieces
Footswitch
Here's an analysis of the provided text regarding the acceptance criteria and study for the Fusion System, extracting the requested information:
Assessment: The provided document is a 510(k) summary for a medical device (Fusion System), which is primarily focused on demonstrating substantial equivalence to a predicate device. While it lists intended uses, it explicitly states "None" for "Performance Data: Results of Clinical Study:", and "None" for "Conclusion:" regarding performance data specific to the Fusion System itself. Therefore, many of the requested details about acceptance criteria, device performance, and study specifics cannot be found in this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| No performance metrics or thresholds are provided in the document. | The document explicitly states "None" for "Results of Clinical Study" and "None" for "Conclusion" regarding performance data. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document states "None" under "Results of Clinical Study".
- Data Provenance: Not specified. No clinical study data is reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable, as no external test set or ground truth establishment is reported for performance evaluation.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Not applicable, as no external test set or adjudication process is reported.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. The document states "None" for "Results of Clinical Study".
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone study was not done or reported. The device is a physical IPL system, not an algorithm. The document explicitly states "None" for "Results of Clinical Study".
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable, as no ground truth was established or used for performance evaluation within this document.
8. The sample size for the training set
- Not applicable, as this device is an Intense Pulsed Light (IPL) system, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable, as this device is an Intense Pulsed Light (IPL) system, not an AI algorithm. Therefore, there is no "training set" or ground truth establishment in this context.
{0}------------------------------------------------
JAN - 5 2010
Attachment 5 510(K) Summary Fusion System
This 510(K) Summary of safety and effectiveness for the Fusion System is submitted in accordance with the requirements of the SMDA 1990 and following quidance concerning the organization and content of a 510(K) summary.
| Applicant: | Eclipsemed Global, Inc |
|---|---|
| ------------ | ------------------------ |
Address:
(
16850 Dallas Parkway Dallas, TX 75248 972-380-2911 - phone 972-380-2953 - fax
972-380-2911 - Phone
972-380-2953 - Fax
Mr. Igor Gradov
Contact Person:
Telephone: Fax: Email:
Preparation Date: October 31, 2009
Device Trade Name: Fusion System
Common Name:
Classification Name:
Legally Marketed Predicate Device:
Lumenis One Family of Systems K060448
The Fusion System consists of:
Footswitch
Instrument, Surgical, Powered, Iaser
Intense Pulse Light (IPL) System
79-GEX, 21 CFR 878-48,
Alma Harmony XL (for treatment of Acne) K072564
Description of the Fusion System:
switching module and isolation transformer Variety of handpieces .
.
.
Intended use of the Fusion System:
The 500 - 1200nm intense pulsed light wavelengths are indicated for:
- The treatment of benign pigmented epidermal lesions. . including dyschromia, hyperpigmentation, melasma, ephelides (freckles)
The main console unit that incorporates the touch-screen
control panel, power supply module, cooling system,
-
. The treatment of cutaneous lesions, including warts, scars and striae
The 560 - 1200nm intense pulsed light wavelengths are indicated for: -
The treatment of benign cutaneous vascular lesions. . including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea. angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
- 1 of 2
{1}------------------------------------------------
Attachment 5 510(K) Summary
Fusion System
Intended use of the Fusion System:
The 600 - 1200nm intense pulsed light wavelengths are indicated for:
- . The removal of unwanted hair from all skin types and to effect stable, long-term or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The 400 - 1200nm intense pulsed light wavelengths are indicated for:
Performance Data: Results of Clinical Study:
Conclusion:
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な
The treatment of moderate inflammatory acne vulgaris. . None None
The Fusion system is substantially equivalent to the previously cleared predicate devices that are currently in commercial distribution.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal on the left and a stylized symbol on the right. The circular seal contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. The symbol on the right is a stylized representation of a human figure, possibly suggesting care or support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
JAN - 5 2010
Eclipsemed Global, Inc. % Mr. Igor Gradov 16850 Dallas Parkway Dallas, Texas 75248
Re: K093465
Trade/Device Name: Fusion System 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: ONF Dated: December 16, 2009 Received: December 22, 2009
Dear Mr. Gradov:
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 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 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 (reporting of medical
{3}------------------------------------------------
Page 2 - Mr. Igor Gradov
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Indications for Use
K093465 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name : Fusion System
Indications for Use:
The 500 – 1200nm intense pulsed light wavelengths are indicated for:
- The treatment of benign pigmented epidermal lesions, including dyschromia, . hyperpigmentation, melasma, ephelides (freckles)
- The treatment of cutaneous lesions, including warts, scars and striae .
The 560 – 1200nm intense pulsed light wavelengths are indicated for:
-
The treatment of benign cutaneous vascular lesions, including port wine stains, . hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations
The 600 - 1200nm intense pulsed light wavelengths are indicated for: -
The removal of unwanted hair from all skin types and to effect stable, long-term . or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The 400 - 1200nm intense pulsed light wavelengths are indicated for: -
The treatment of moderate inflammatory acne vulgaris. .
Prescription Use xx (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)
Page 1 of 1
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
510(k) Number
§ 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.