(60 days)
Not Found
No
The summary describes a standard Intense Pulsed Light (IPL) system with various handpieces and controls, and there is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies sections.
Yes
The device is indicated for the treatment of various medical conditions, including benign pigmented epidermal lesions, cutaneous lesions (warts, scars, striae), benign cutaneous vascular lesions, and moderate inflammatory acne vulgaris, which are all therapeutic indications.
No
The provided text only describes the device's indications for treatment, such as benign pigmented epidermal lesions, cutaneous lesions, vascular lesions, and hair removal. It does not mention any diagnostic capabilities.
No
The device description explicitly lists hardware components such as a main console unit, handpieces, and a footswitch, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device uses Intense Pulsed Light (IPL) wavelengths to treat various skin conditions and remove unwanted hair. This is a therapeutic device that directly interacts with the patient's body, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended uses listed are all related to treating conditions on the skin (cutaneous lesions, pigmented lesions, vascular lesions, acne) and hair removal. None of these involve analyzing biological samples for diagnostic purposes.
Therefore, the Fusion System described is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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. .
Product codes
ONF
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light
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
None
Description of the test set, sample size, data source, and annotation protocol
None
Summary of Performance Studies
Results of Clinical Study: None
Conclusion: The Fusion system is substantially equivalent to the previously cleared predicate devices that are currently in commercial distribution.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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.
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 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