(405 days)
Not Found
No
The document describes a pulsed light system with a Xenon flashlamp and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, and treatment of benign pigmented lesions, all of which are medical treatments for conditions.
No
The device description and intended use outline therapeutic applications (hair reduction, treatment of lesions), not the identification or diagnosis of diseases or conditions.
No
The device description clearly states it is a pulsed light system with a Xenon flashlamp in the handpiece, a physical light source, and a significant weight and size, indicating it is a hardware device.
Based on the provided information, the Minisilk FT pulsed light device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for procedures performed on the patient's body (hair reduction, vascular lesions, pigmented lesions). IVDs are used to examine specimens from the body (like blood, urine, tissue) to diagnose or monitor conditions.
- Device Description: The description details a light-emitting system applied externally. This is consistent with a therapeutic or aesthetic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Minisilk FT is a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Minisilk FT pulsed light device is indicated for permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels and treatment of benign pigmented lesions.
Product codes
ONF
Device Description
The Minisilk_FT is a pulsed light system having a Xenon flashlamp located in the handpieces. It is a light source emitting in the wavelength range 500-1200 nm.
Emission activation is by footswitch. Overall weight of the system is 16 kg, and the size is 22x37x45 cm (H x W x D).
Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.
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)
Nonclinical Performance Data: None Clinical Performance Data: None
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
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
510(K) Summary
El.En. S.p.A.
via Baldanzese, 17
50041 Calenzano (FI), Italy
Phone: +39-055-882-6807 Fax: +39-055-883-2884
Email: info@elengroup.com
Andrea Tozzi
Quality System Manager & Official Correspondent
via Baldanzese, 17
50041 Calenzano (FI), Italy
Phone: +39-055-882-6807 Fax: +39-055-883-2884
Email: a.tozzi@elen.it
August 26th, 2009
Minisilk_FT
Intense Pulsed Light System
Powered light based non-laser surgical instrument with thermal effect
ONF
21 CFR 878.4810
Cynosure Photolight PL - K031258
The Minisilk_FT is a pulsed light system having a Xenon flashlamp
pg 1 of 1
AUG 2 7 2009
located in the handpieces. It is a light source emitting in the wavelength
Emission activation is by footswitch. Overall weight of the system is 16
Electrical requirement is: 115 VAC, 10A, 50-60 Hz, single phase.
The Minisilk FT pulsed light device is indicated for permanent hair
reduction, photocoagulation of vascular lesions, photothermolysis of
The Minisilk FT is another safe and effective device for permanent hair
reduction, photocoagulation of vascular lesions, photothermolysis of
blood vessels and treatment of benign pigmented lesions.
blood vessels and treatment of benign pigmented lesions.
Device Description:
Equivalent Devices:
Date Summary Prepared:
Device Trade Name:
Classification Name:
Common Name:
Submitter:
Contact:
Indications for Use:
Comparison:
The Minisilk FT system has the same indications for use, the same principle of operation, and essentially the same wavelength range and pulse energy range as the predicate device.
kg, and the size is 22x37x45 cm (H x W x D).
range 500-1200 nm.
Nonclinical Performance Data: None Clinical Performance Data: None
Conclusion:
Additional Information:
None
1
Image /page/1/Picture/13 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with its wings spread, suggesting themes of protection and national identity.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
El. En. S.p.A. % Ms. Andrea Tozzi Quality System Manager & Official Correspondent Viaa Baldanzese, 17 50041 Calenzano (FI) - Italy
AUG 2 7 2009
Re: K082040
Trade/Device Name: Minisilk FT 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: ONF
Dated: August 5, 2009 Received: August 10, 2009
Dear Mr. Tozzi:
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 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.
2
Page 2 - Ms. Andrea Tozzi
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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (240) 276-3150 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
pg 1 of
510(K) Number (if known): K082040
Device Name: ____ Minisilk_FT____
Indications For Use:
The Minisilk FT pulsed light device is indicated for permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels and treatment of benign pigmented lesions.
Prescriptive Use (Part 21 CFR 801 Subpart D) OR
Over-the-Counter Use (Part 21 CFR 801 Subpart C)
(PLEASE NO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mial R. Ogle forman
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number
(Optional Format 1-2-96)