(84 days)
No
The summary describes a laser and pulsed light platform for aesthetic treatments, focusing on hardware components and treatment parameters. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for treatments of medical conditions like vascular lesions, benign pigmented lesions, warts, and teleangiectasia, classifying it as a therapeutic device.
No
The Deka Synchro FT is described as a device used for treatments such as hair removal, photocoagulation, and treatment of various skin lesions, not for diagnosing conditions.
No
The device description clearly indicates a physical platform with a laser module, pulsed light handpiece, and significant weight and dimensions, indicating it is a hardware device.
Based on the provided information, the Deka Synchro FT is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended uses listed are all for therapeutic treatments performed directly on the patient's body (hair removal, treatment of vascular and pigmented lesions). IVDs are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a laser and pulsed light system designed for external application to the skin. This aligns with a therapeutic device, not a device for analyzing 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 IVD devices.
Therefore, the Deka Synchro FT is a therapeutic medical device, not an IVD.
N/A
Intended Use / Indications for Use
The Deka Synchro FT is indicated for the following treatments:
Nd: YAG laser: Removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions..
Pulsed light attachment: Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions.
Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types, as indicated in the following table:
| Pulsed light
| wavelength range | Hair reduction | Vascular lesions | Blood vessels | Pigmented lesions |
|---|---|---|---|---|
| 500 - 1200nm | - | Skin Types I, II | Skin Types I, II | - |
| 520 - 1200nm | - | Skin Type III | Skin Type III | Skin Types I, II |
| 550 - 1200nm | Skin Types I, II | - | - | Skin Type III |
| 600 - 1200nm | Skin Type III | - | - | - |
| 650 - 1200nm | Skin Type IV | - | - | Skin Type IV |
Product codes
GEX, ONF
Device Description
The Deka Synchro FT is a platform which can be equipped with an internal hi-power long pulse Nd:YAG laser module and a pulsed light handpiece (FT handpiece). SynchroFT with the long pulse Nd:YAG module comes with a wide range of interchangeable, quick release handpieces with electronic spot recognition. The FT handpiece is equipped with five different emission spectra interchangeable filters. The system allows to switch from one of the two available sources to the other by pressing a key on keyboard. Handpiece activation is either by footswitch or fingerswitch.
Overall weight of the device is 65 kg, and the size is 100 cm x 50 cm x 83 cm (H x W x D). Electrical requirement is 230VAC, 16A, 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
JAN 3 1 2011
Submitter:
Contact:
Date Summary Prepared:
Device Trade Name:
Common Name:
Classification Name:
Equivalent Devices:
Device Description:
Intended Use:
El.En. S.p.A. via Baldanzese, 17 50041 Calenzano (FI), Italy
Paolo Peruzzi Senior Regulatory Affairs Engineer & Official Correspondent Phone: +39.055.8826807 E-mail: standards@elen.it
January 28, 2010
Deka Synchro FT
Medical laser and pulsed light system
Laser Surgical Instrument for use in General and Plastic Surgery and in Dermatology (21 CFR 878.4810)
El.En. Synchro HP Platform (K082039), El.En. Minisilk FT (K082040)
The Deka Synchro FT is a platform which can be equipped with an internal hi-power long pulse Nd:YAG laser module and a pulsed light handpiece (FT handpiece). SynchroFT with the long pulse Nd:YAG module comes with a wide range of interchangeable, quick release handpieces with
electronic spot recognition. The FT handpiece is equipped with five different emission
spectra interchangeable filters. The system allows to switch from one of the two available
sources to the other by pressing a key on keyboard. Handpiece activation is either by footswitch or fingerswitch.
Overall weight of the device is 65 kg, and the size is 100 cm x 50 cm x 83 cm (H x W x D).
Electrical requirement is 230VAC, 16A, 50-60 Hz, single phase.
The Deka Synchro FT is indicated for the following treatments:
Nd: YAG laser: Removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions..
Pulsed light attachment: Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions.
1
Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types, as indicated in the following table:
| Pulsed light
| wavelength range | Hair reduction | Vascular lesions | Blood vessels | Pigmented lesions |
|---|---|---|---|---|
| 500 - 1200nm | - | Skin Types I, II | Skin Types I, II | - |
| 520 - 1200nm | - | Skin Type III | Skin Type III | Skin Types I, II |
| 550 - 1200nm | Skin Types I, II | - | - | Skin Type III |
| 600 - 1200nm | Skin Type III | - | - | - |
| 650 - 1200nm | Skin Type IV | - | - | Skin Type IV |
.
| Comparison: | The Deka Synchro FT is substantially equivalent to the El.En.
Synchro HP Platform as regards the Nd:YAG laser and to the
El.En. Minisilk FT as regards the Pulsed light attachment.
The Deka Synchro FT has the same indications for use as the
abovementioned predicate devices, with same principle of
operation and essentially the same performances. |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Nonclinical Performance Data: | None |
| Clinical Performance Data: | None |
| Conclusion: | The Deka Synchro FT is a safe and effective device for the
indications specified above. |
| Additional Information: | None |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
El.En. S.p.A. % Mr. Paolo Peruzzi Senior Regulatory Affairs Engineer via Baldanzese, 17 50041 Calenzano (FI), Italy
JAN 3 1 2011
Re: K103288
Trade/Device Name: Deka Synchro FT 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: GEX, ONF Dated: January 18, 2011 Received: January 20, 2011
Dear Mr. Peruzzi:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
and the country of the country of the county of the county of
3
Page 2 - Mr. Paolo Peruzzi
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.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
A. B. Rote
fr
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(K) Number (if known): K103288
Device Name: --Deka Synchro FT
Indications For Use:
The Deka Synchro FT is indicated for the following treatments:
Nd: Y AG laser: Removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions.
Pulsed light attachment: Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions.
Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types, as indicated in the following table:
| Pulsed light
| wavelength range | Hair reduction | Vascular lesions | Blood vessels | Pigmented lesions |
|---|---|---|---|---|
| 500 - 1200nm | - | Skin Types I, II | Skin Types I, II | - |
| 520 - 1200nm | - | Skin Type III | Skin Type III | Skin Types I, II |
| 550 - 1200nm | Skin Types I, II | - | - | Skin Type III |
| 600 - 1200nm | Skin Type III | - | - | - |
| 650 - 1200nm | Skin Type IV | - | - | Skin Type IV |
Prescriptive Use (Part 21 CFR 801 Subpart D) 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)
Nel R.E.Bden formxn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
OR
510(k) Number K103288
(Optional Format 1-2-96)