(231 days)
The DEKA Synchro Repla:Y family of laser systems is indicated for:
755mn laser:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6.9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick I - VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
l 064nm laser:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.
Pulsed light FT handpiece:
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 lightwavelength 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 |
The Deka Synchro Repla: Y family of lasers is a platform which can be equipped with two separate solid state laser heads (755nm and 1064nm) and a pulsed light handpiece (FT handpiece).
The two laser heads can only be activated separately and they deliver the laser output through the same single laser delivery system, consisting of a lens coupled user replaceable optical fiber with a wide range of interchangeable, quick release laser handpieces with electronic spot recognition.
The FT handpiece delivers the pulsed light to the treatment area by means of a sapphire lightguide: it is provided with has an integrated skin cooling system and is equipped with five different emission spectra interchangeable filters.
The system allows to switch from one of the three available sources to the other by pressing a key on touch panel.
Handpiece activation is either by footswitch or fingerswitch.
This document is a 510(k) summary for a medical laser system and does not contain information about acceptance criteria or a study proving its performance in the context of an AI/algorithm-based device as typically presented in such studies. The device is a physical laser system, not an AI or software algorithm that provides diagnostics or interpretations.
The document discusses "Clinical Performance Data: None" and "Non-Clinical Performance Data: Performance data has been provided in order to show that the Deka Synchro Repla: Y Software complies with the Requirements of the 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices' issued by the FDA on May 11, 2005. Moreover, performance data has been provided in order to show that the Deka Synchro Repla: Y complies with the EMC requirements of the FDA Recognized Standard IEC 60601-1-2 and with the FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities."
This statement indicates that the software performance data is primarily about compliance with regulatory guidance for medical device software and EMC standards, not about clinical effectiveness as you would expect for an AI algorithm making diagnostic predictions.
Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, sample sizes, expert ground truth, or AI performance metrics because this information is not present in the provided text for this type of device. The provided text is a 510(k) summary for a physical medical laser device establishing substantial equivalence to predicate devices based on technical specifications and intended use, not clinical performance data for an AI-powered diagnostic or assistive tool.
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.
510(K) Summary
| Submitter: | El.En. S.p.A.via Baldanzese, 1750041 Calenzano (FI), ItalyDEC 0 5 2013 |
|---|---|
| Contact: | Paolo PeruzziRegulatory Affairs Manager & Official CorrespondentPhone: +39.055.8826807E-mail: standards@elen.it |
| Date Summary Prepared: | December 05, 2013 |
| Device Trade Name: | Deka Synchro Repla:Y family of Laser Systems |
| Common Name: | Medical Laser and pulsed Light system |
| Classification Name: | Laser Surgical Instrument for use in General andPlastic Surgery and in Dermatology (GEX) |
| Classification Number | 21 CFR 878.4810 |
| Equivalent Devices: | Candela GentleMAX family of laser systems (K122715):Deka Synchro FT (K103288). |
| Device Description: | The Deka Synchro Repla: Y family of lasers is a platformwhich can be equipped with two separate solid state laserheads (755nm and 1064nm) and a pulsed light handpiece (FThandpiece).The two laser heads can only be activated separately and theydeliver the laser output through the same single laser deliverysystem, consisting of a lens coupled user replaceable opticalfiber with a wide range of interchangeable, quick release laserhandpieces with electronic spot recognition.The FT handpiece delivers the pulsed light to the treatmentarea by means of a sapphire lightguide: it is provided with hasan integrated skin cooling system and is equipped with fivedifferent emission spectra interchangeable filters.The system allows to switch from one of the three availablesources to the other by pressing a key on touch panel.Handpiece activation is either by footswitch or fingerswitch. |
| Intended Use: | 755mn laser:Temporary hair reduction.Stable long-term or permanent hair reduction through selectivetargeting of melanin in hair follicles. Permanent hair reductionis defined as the long-term, stable reduction in the number ofhairs regrowing when measured at 6.9, and 12 months after the |
{1}------------------------------------------------
completion of a treatment regime. On all skin types (Fitzpatrick I - VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
l 064nm laser:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains,
hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.
Pulsed light FT handpiece:
Permanent hair reduction, photocoagulation of vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions.
Substantial equivalence discussion
The DEKA Synchro Repla: Y family of laser systems is substantially equivalent to the Candela Gentle MAX family of laser systems as regards the 755nm and 1064nm laser, with similar performances and technology.
| Device TradeName | DEKA SynchroRepla: Y family of lasersystems | Predicate DeviceK122715Candela GentleMAxfamily of laser systems |
|---|---|---|
| Laser Type | Alexandrite, Nd:YAG | Alexandrite, Nd:YAG |
| Wavelength | 755 nm, 1064 nm | 755 nm, 1064 nm |
| Max Fluence | 600 J/cm² | 600 J/cm² |
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| Spot Sizes | 2.5 to 20mm | 1.5 to 18 mm |
|---|---|---|
| Pulse Duration | 0.25 to 300 ms | 0.25 to 300 ms |
| Pulse Rep Rate | up to 10 Hz | up to 10 Hz |
| Skin Cooling System | Yes, optional | Yes, optional |
The DEKA Synchro Repla: Y family of laser systems is substantially equivalent to the DEKA Synchro FT as regards the Pulse Light handpiece, with identical performances and technology.
| Device TradeName | DEKA SynchroRepla: Y family of lasesystems | Predicate DeviceK103288DEKA Synchro FT |
|---|---|---|
| Device Type | Pulsed Flashlamp | Pulsed Flashlamp |
| Wavelengths(nm) | 500 - 1200nm520 - 1200nm550 - 1200nm600 - 1200nm650 - 1200nm | 500 - 1200nm520 - 1200nm550 - 1200nm600 - 1200nm650 - 1200nm |
| Pulse Width | 3 - 124 ms | 3 - 124 ms |
| Fluence | 3 - 25 J/cm² | 3 - 25 J/cm² |
| Repetition Rate | 0.5 Hz max. | 0.5 Hz max. |
| Spot Sizes | 48x13 mm | 48x13 mm |
| Method of SkinCooling | Integrated - providedvia the handpiecelightguide | Integrated - providedvia the handpiecelightguide |
| Method ofOutput | Direct DeliveryHandpiece | Direct DeliveryHandpiece |
The DEKA Synchro Repla: Y family of laser systems has the same indications for use as the abovementioned predicate devices, with same principle of operation and essentially the same performances.
Clinical Performance Data: None Non-Clinical Performance Data: Performance data has been provided in order to show that the Deka Synchro Repla: Y Software complies with the Requirements of the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued by the FDA on May 11, 2005. Moreover, performance data has been provided in order to show that the Deka Synchro Repla: Y complies with the EMC
{3}------------------------------------------------
requirements of the FDA Recognized Standard IEC 60601-1-2 and with the FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities.
The Deka Synchro Repla:Y family of laser systems is a family Conclusion: of safe and effective devices for the applications mentioned above.
Additional Information:
None
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
EL. EN Electronic Engineering SPA Paolo Peruzzi Regulatory Affairs Manager Via Baldanzese 17 Calenzano, Florence 50041 ITALY
December 5, 2013
Re: K131095
Trade/Device Name: Deka Synchro Repla: Y family of laser systems 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 Dated: October 18, 2013 Received: October 21, 2013
Dear 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.
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
{5}------------------------------------------------
Page 2 - Paolo Peruzzi
CFR Part 807); labeling (21 CFR Part 801); medical device 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 clectronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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.
Joshua C. Nipper -S
Binita S. Ashar. M.D., M.B.A., F.A.C.S. For Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(K) Number (if known):_ K131095
Device Name: Deka Synchro Repla: Y family of laser systems
Indications For Use:
The DEKA Synchro Repla:Y family of laser systems is indicated for:
755mn laser:
Temporary hair reduction.
Stable long-term or permanent hair reduction through selective of melanin in hair follicles. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime. On all skin types (Fitzpatrick 1 - VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
Photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
Prescription Use X
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(Please DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) Neil R Ogden 2013.12.04 15:44: 31 -05.00
(Division Sign-Off) For BSA
Division of Surgical Devices
510(k) Number_K131095
Page 1 of 3
{7}------------------------------------------------
1064nm laser:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB . The lasers are indicated on all Skin Types Fitzpatrick 1-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions, such as but not limited to port wine stains, hemangioma, warts, teleangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos, (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratosis, nevi, cloasma, verrucae, skin tags, keratosis and plaques.
The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.
The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Prescription Use X
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
{Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) Neil R Ogden :: 2013.12.04 45.44
(Division Sign-Off) For BSA
Division of Surgical Devices
510(k) Number_K131095
Page 2 of 3
{8}------------------------------------------------
Pulsed light FT handpiece:
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 lightwavelength 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 |
Prescription Use X
AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(Please do NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH) Neil R Ogdem: 2013.12.04 15:45:12 -05'00'
(Division Sign-Off) For BSA
Division of Surgical Devices
510(k) Number K131095
Page 3 of 3
§ 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.