FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling a caduceus, with three figures in profile facing right, representing the department's focus on health and human well-being. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 December 8, 2016 Bios S.R.L. Manuela Brambilla Regulatory and Quality Assistant Via Guido Rossa, 10/12 Vimodrone, Milan I-20090 IT Re: K161632 Trade/Device Name: Family Of Square Epil (Alex, Alex2, Nd: YAG, Alex+Nd:YAG) 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: November 2, 2016 Received: November 14, 2016 Dear Manuela Brambilla: 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device {1}------------------------------------------------ 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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. Image /page/1/Picture/8 description: The image shows the name "Jennifer R. Stevenson - A" in a large, clear font. The text is arranged vertically, with "Jennifer R." on the top line and "Stevenson - A" on the bottom line. The background is plain and does not distract from the text. For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use ### 510(k) Number (if known) K161632 ### Device Name FAMILY OF SQUARE EPIL (Square Epil Alex, Square Epil Nd:Yag, Square Epil Nd:Yag, Square Epil Alex+Nd: Yag) Indications for Use (Describe) The Nd: Yag 1064 Laser is intended for: - Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment 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. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. - Photocoagulation and hemostasis of benign pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. - Coagulation and hemostasis of soft tissue. - Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, sebortheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments. - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. - Treatment of wrinkles. The Nd:Yag 1064 Laser is intended for: - Temporary increase of clear nail in patients with onychomycosis (e.g., derniatophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.) The Alexandrite 755 laser is intended for: - 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 benign vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). | Type of Use (Select one or both, as applicable) | | | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | <table border="0"><tr><td><div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div></td></tr><tr><td><div> <span> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div></td></tr></table> | <div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | | <div> <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | | | | <div> <span> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | | | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # Section 5 510(k) Summary #### SUBMITTER I. | Applicant Information | Bios s.r.l. | |-----------------------|-------------------------------------------------------------------------------------------------------------| | | Via Guido Rossa, 10/12 | | | 20090 Vimodrone (MI) – Italy | | Contact | Ing. Aldo Casalino | | Date Prepared | 7 June 2016 | | II. DEVICE | | | Device Trade Name | FAMILY OF SQUARE EPIL (Square Epil Alex, Square Epil Alex2, Square<br>Epil Nd:Yag, Square Epil Alex+Nd:Yag) | | Common Name | Medical Laser System | | Regulatory class | II | | Classification Name | Laser surgical instrument for use in general and plastic surgery and in<br>dermatology (21 CFR 878.4810) | | Product Code | GEX | #### PREDICATE DEVICE III. | 510(k) Number | Pro Code | Trade Name | Applicant | |---------------|---------------------|---------------------|------------------------------------------| | K150516 | GEX 21 CFR 878.4810 | DEKA Synchro | El. En. Electronic<br>Engineering S.p.A. | | K140122 | GEX 21 CFR 878.4810 | Candela Corporation | GentleMAX Family of<br>Laser Systems | #### Device Description IV. The FAMILY OF SQUARE EPIL LASER , is a laser equipped with one or two solid-state laser sources: As shown in the previous table, the 4 configurations of the Family differ for the internal crystals of the sources, that can be Alexandrite and/or Nd:YAG. The emitted laser radiation has a wavelength of 755nm, respectively, and 1064nm: -Alex configuration has only one source and one wavelength available (755 nm). -Alex configuration has two sources of the same wavelength (755 nm), in order to increase the maximum power available. {5}------------------------------------------------ -Nd:Yag configuration has only one source and one wavelength available (1064 nm). -In the Alex+Nd: Yag configuration has both the two wavelengths available (755 nm and 1064 nm) but can act only individually, simultaneous operations are not allowed. This device is intended for medical use only. #### V. Indication for Use The Nd:Yag 1064 Laser is intended for: Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of benign pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafè au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for benign pigmented lesions to reduce lesion size, for patients with benign lesions that would potentially benefit from aggressive treatment, and for patients with benign lesions that have not responded to other laser treatments. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. The Nd:Yag 1064 laser is intended for: Temporary increase of clear nail in patients with onychomycosis (e.g., derniatophytes, Trichophyton rubrum and T. mentagrophytes, and for yeast Candida Albicans, etc.). {6}------------------------------------------------ The Alexandrite 755 laser is intended for: Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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. The photocoagulation of dermatological benign vascular lesions (such as pant-wine stains, hemangiomas, telangiectasias) #### VI. Comparison of Technological Characteristics with the Predicate Devices The product specification, functionality, indication for use, and treatment parameters of the FAMILY OF SQUARE EPIL LASER are the same or very similar to the legally marketed, claimed predicate devices for the purpose of this 510(k) submission. The general features of FAMILY OF SQUARE EPIL LASER are similar to those of the predicates in particular as regards the classification IV laser and the electrications. Also the predicate devices are equipped with a touch screen and with a control SW. The physical characteristics of FAMILY OF SQUARE EPIL LASER (weight and size) are also comparable with those of the predicates. The intended use of each configuration of FAMILY OF SOUARE EPIL LASER are identical to those of the predicates and also the technical characteristics are the same. In particular: - Nd:Yag source of FAMILY OF SQUARE EPIL LASER with the wavelength of 1064 mm applies । a maximum energy in the same range of DEKA Synchro K150516 and the GentleMAX Family of Laser Systems K140122. The emission frequency of the Nd: Yag source of FAMILY OF SQUARE EPIL LASER is the same of DEKA Synchro K150516 and the GentleMAX Family of Laser Systems K140122. {7}------------------------------------------------ - Nd:Yag Source of FAMILY OF SQUARE EPIL LASER with the wavelength of 1064 nm, are shown operative parameters for a specific application (Temporary increase of clear nail in patients with onychomycosis). These parameters are identical to the predicate device GentleMAX Family of Laser Systems K140122. - Alexandrite source of FAMILY OF SQUARE EPIL LASER with the wavelength of 755 nm applies a maximum energy in the same range of DEKA Synchro K150516 and the GentleMAX Family of Laser Systems K140122. The emission frequency of the Alexandrite source of FAMILY OF SQUARE EPIL LASER are comparable to DEKA Synchro K150516 and the GentleMAX Family of Laser Systems K140122. #### Performance Data VII. # Biocompatibility testing The FAMILY OF SQUARE EPIL LASER is classified as a surface device (≤ 24 hours contact duration) in contact with skin in accordance with ISO 10993. The patient contacting materials for the device and accessories are all well known for their compatibility. # Electrical safety and EMC The FAMILY OF SQUARE EPIL LASER has been tested and is in compliance with: - EN 60601-1, Medical electrical equipment. Part 1: General requirements for basic safety and essential performance 2006/A11:2010/A1:2013, EN 60601-2-22:2013 Medical electrical equipment; - l EN60601-1-2 Medical electrical equipment. Part1: General requirements for safety - Collateral standard: Electromagnetic Compatibility - Requirements and tests. # Software verification and validation testing Software verification and validation was conducted according to FDA regulations, standards and guidance document requirements. The results of this testing conclude the software has met these requirements. Design verification and validation was also performed on the FAMILY OF SQUARE EPIL LASER in compliance with internal design control procedures. {8}------------------------------------------------ # Usability testing Usability of the FAMILY OF SQUARE EPIL LASER have been tested in accordance with the standard EN 60601-1-6:2010 ### Pre series test Pre-series tests have been performed to support the evidence that performances of FAMILY OF SQUARE EPIL LASER are aligned with the identified intended uses. ### Animal and clinical study Animal and clinical studies were not necessary to demonstrate that the permormances are comparable to the predicate devices. ## VIII. Conclusions BIOS s.r.l. has determined, by using comparisons and tests, that FAMILY OF SQUARE EPIL LASER is substantially equivalent to the listed predicate devices in terms of intended use, typical clinical use, operational characteristics, and fundamental technological characteristics. Any differences are considered minor and do not raise new issues of the safety and effectiveness of the FAMILY OF SQUARE EPIL LASER device when compared to the predicate devices.