(231 days)
Not Found
No
The document describes a laser and pulsed light system for various dermatological treatments. There is no mention of AI or ML in the intended use, device description, or performance studies. The performance studies focus on software compliance and EMC requirements, not AI/ML performance.
Yes
The device is indicated for various medical treatments, including temporary and permanent hair reduction, treatment of benign pigmented lesions, treatment of wrinkles, photocoagulation of dermatological vascular lesions, removal of unwanted hair, treatment of PFB, and coagulation and hemostasis of soft tissue. These are all therapeutic applications.
No
The device is indicated for various cosmetic and dermatological treatments (e.g., hair reduction, treatment of pigmented lesions, wrinkles, vascular lesions) and does not perform diagnostic functions.
No
The device description clearly outlines a physical laser system with multiple hardware components (laser heads, handpieces, optical fiber, filters, footswitch, fingerswitch). While there is mention of software compliance testing, the core device is a hardware-based laser system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The DEKA Synchro Repla:Y family of laser systems is described as a platform that uses lasers and pulsed light for various dermatological and cosmetic treatments performed directly on the patient's body (e.g., hair reduction, treatment of lesions, wrinkle reduction).
- Lack of Sample Analysis: There is no mention of this device analyzing samples taken from the body. Its function is to apply energy to the body.
Therefore, the intended use and device description clearly indicate that this is a therapeutic device used for external treatments, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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).
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.
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 light wavelength range: 500 - 1200nm for Vascular lesions Skin Types I, II, Blood vessels Skin Types I, II.
Pulsed light wavelength range: 520 - 1200nm for Vascular lesions Skin Type III, Blood vessels Skin Type III, Pigmented lesions Skin Types I, II.
Pulsed light wavelength range: 550 - 1200nm for Hair reduction Skin Types I, II, Pigmented lesions Skin Type III.
Pulsed light wavelength range: 600 - 1200nm for Hair reduction Skin Type III.
Pulsed light wavelength range: 650 - 1200nm for Hair reduction Skin Type IV, Pigmented lesions Skin Type IV.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
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)
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 requirements of the FDA Recognized Standard IEC 60601-1-2 and with the FDA/CDRH Recommendations for EMC/EMI in Healthcare Facilities.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
| Submitter: | El.En. S.p.A.
via Baldanzese, 17
50041 Calenzano (FI), Italy
DEC 0 5 2013 |
|------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Paolo Peruzzi
Regulatory Affairs Manager & Official Correspondent
Phone: +39.055.8826807
E-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 and
Plastic 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 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. |
| Intended Use: | 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 |
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 Trade
Name | DEKA Synchro
Repla: Y family of laser
systems | Predicate Device
K122715
Candela GentleMAx
family 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 |
2
| 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 Trade
Name | DEKA Synchro
Repla: Y family of lase
systems | Predicate Device
K103288
DEKA Synchro FT |
|---------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Device Type | Pulsed Flashlamp | Pulsed Flashlamp |
| Wavelengths
(nm) | 500 - 1200nm
520 - 1200nm
550 - 1200nm
600 - 1200nm
650 - 1200nm | 500 - 1200nm
520 - 1200nm
550 - 1200nm
600 - 1200nm
650 - 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 Skin
Cooling | Integrated - provided
via the handpiece
lightguide | Integrated - provided
via the handpiece
lightguide |
| Method of
Output | Direct Delivery
Handpiece | Direct Delivery
Handpiece |
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
6
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 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 |
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