Who is the manufacturer of DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS?

El.En Electronic Engineering Spa filed the 510(k) submission for DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS (K131095).

What is the FDA product code for DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS?

Candela GentleMAX family of laser systems (K122715); Deka Synchro FT (K103288).

Who can help prepare an FDA 510(k) submission like DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS

K131095 · El.En Electronic Engineering Spa · GEX · Dec 5, 2013 · General, Plastic Surgery

Device Facts

Record ID	K131095
Device Name	DEKA SYNCHRO REPLA: Y FAMILY OF LASER SYSTEMS
Applicant	El.En Electronic Engineering Spa
Product Code	GEX · General, Plastic Surgery
Decision Date	Dec 5, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

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 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). 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 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.

Device Story

Platform-based laser system utilizing two solid-state laser heads (755nm Alexandrite, 1064nm Nd:YAG) and a pulsed light (FT) handpiece. Inputs include user-selected parameters via touch panel; system delivers energy through a lens-coupled optical fiber with interchangeable handpieces featuring electronic spot recognition. FT handpiece uses sapphire lightguide with integrated skin cooling and interchangeable spectral filters. Operated by clinicians in professional settings; activation via footswitch or fingerswitch. Output is controlled light/laser energy for photothermolysis, photocoagulation, and hemostasis. Clinical benefit includes hair reduction, lesion removal, and scar management. System allows switching between sources via touch panel interface.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-1-2 (EMC/EMI) and FDA software guidance provided. No clinical data presented.

Technological Characteristics

Solid-state laser (Alexandrite 755nm, Nd:YAG 1064nm) and pulsed flashlamp (500-1200nm). Fluence up to 600 J/cm² (laser) and 3-25 J/cm² (pulsed light). Spot sizes 2.5-20mm (laser) and 48x13mm (pulsed light). Integrated sapphire lightguide cooling. Touch panel interface with electronic spot recognition. Software-controlled emission.

Indications for Use

Indicated for hair reduction, treatment of benign pigmented lesions, wrinkles, and vascular lesions (e.g., port-wine stains, hemangiomas, telangiectasias, leg veins, rosacea) in patients of all Fitzpatrick skin types (I-VI), including tanned skin. Also indicated for soft tissue coagulation/hemostasis and reduction of red pigmentation in hypertrophic/keloid scars.

Regulatory Classification

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.

Predicate Devices

Candela GentleMAX family of laser systems (K122715)
Deka Synchro FT (K103288)

Related Devices

K150516 — DEKA SYNCHRO REPLA:Y FAMILY OF LASER SYSTEMS · El.En Electronic Engineering Spa · Apr 13, 2015
K181486 — DEKA Motus AY · El.En Electronic Engineering Spa · Aug 30, 2018
K130256 — MDK MULTI-APPLICATIONS PLATFORM · Quanta System Spa · Jul 2, 2013
K063074 — CANDELA 3630 LASER SYSTEM · Candela Corp. · Dec 27, 2006
K070805 — ULTRAWAVE II EX 1320 · Quanta System Spa · Jul 11, 2007

Submission Summary (Full Text)

{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