BLUESHINE'S GOLD SERIES

{0}------------------------------------------------ 11 0375 Page 1 of (6) Title: # 510(k) SUMMARY Blueshine's GOLD series FEB 2 3 202 | Submitter: | Blueshine srl via Querini,27 30171, Mestre Venezia<br>Italy<br>Contact person Chiara Ricci CEO<br>+390415055847<br>blueshine@blueshine.biz | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact: | Chiara Ricci<br>C.E.O. | | Date Prepared: | Dec. 01, 2011 | | Device Trade Name: | Blueshine's GOLD series | | Common Name: | Laser surgical instrument for use in general and plastic<br>surgery and in dermatology | | Classification<br>Name: | Instrument, surgical, powered, laser<br>GEX<br>21 C.F.R. 878.4810 | | Predicate Devices: | • Quanta System S.p.A. Diode Medical Laser<br>Family (K072034)<br>• Osyris, Pharaon Lipo (K073617)<br>• Pinpointe, Pinpointe Footlaser (K093547) | | Summary of<br>Onychomycosis<br>Clinical data | Abstract: A 6-month follow-up study was conducted on<br>48 patients who received laser treatment for<br>onychomycosis with Gold Series 980 Diode Laser<br>(BlueShine, Venice - Italy).<br>Objective To examine long-term cure and relapse rates<br>after treatment with a 2 millisecond-pulse 980 nm near-<br>infrared laser in onychomycosis.<br>Setting Two private practices in Padua and Venice, Italy.<br>Subjects & Methods The study population comprised 48<br>patients (31 male & 17 female) aged 23 to 79 years with a<br>clinical and mycological diagnosis of onychomycosis.<br>The Laser treatment consisted of 3 /4 sessions with 30<br>days interval. Each nail was treated with 2 alternating<br>passes of laser pulses to cover the full nail, one pass<br>applied vertically down each nail and the second applied | {1}------------------------------------------------ K110375 Page 2 of (6) horizontally using defocused hand piece with 3 mm spot size. The BlueShine Gold Series 980 Diode Laser has proven highly efficient against Onychomycosis. This protocol gives excellent results on almost all the nails treated and in a short time span. The procedure is simple and quick with no noticeable side effects and complications. Despite the high success rate, our laser treatment is not a definitive cure for onychomycosis. Therefore and because it can recur, preventative maintenance treatments might be recommended every 6 months. The use of Blueshine Gold Series diode Laser on patients affected by Onycomycosis with different pathologies, has a significant, positive results. On the 48 nails we found that , totally, 93,75 % have improved at least for 1/3 of the nail plate and no one was worse. 6,25 % were unchanged. On the total eligible toenails (48) 45 presented some improvement and, much more important, 37 of these (77,09) showed complete clear nails, while just 8 presented middle or moderate clear. ### First session % fungus | 50-75 | 10(21%) | |-------|-----------| | 75-90 | 10 (21%) | | >90 | 28 (58%) | | Total | 48 (100%) | All nails are checked visually and classified as: - 1. Unchanged means there were no result or the nail were missed or < 1/3: - 2. Middle cleared means that the improvement was 1/3 to 2/3: - 3. completely cleared means that the improvement was > 2/3. | Results | | |----------------|-----------| | Unchanged | 3 (6%) | | Middle clear | 8 (17%) | | Complete clear | 37 (77%) | | Total | 48 (100%) | {2}------------------------------------------------ 11035 Page 3 of 6 Intended Use / Indications for Use: ### 980nm Wavelengths The Blueshine GOLD series , (and the fiber delivery systems and accessories used to deliver laser energy), is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology (GYN), pulmonology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry. The Blueshine GOLD series Laser is indicated for use in the performance of specific surgical applications in gastroenterology, neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology {GYN), pulmonology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry as follows: #### Gastroenterology The ablation, vaporization, excision, incision, and coagulation of soft ussue in gastroenterology procedures. Applications include: hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis of colonoscopy. ### Neurosurgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in neurosurgery procedures. Applications include: tumors adjacent to the spinal cord; tumors adjacent to the cortex. ### General Surgery Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein. The ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Applications include: Laparoscopic: appendectomy; cholecystectorny; bowel resection. Open: mastectomy; reduction mammoplasty; breast biopsy; rectal and anal hemorrhoidectomy; bowel resection; colectomy; cholecystectomy; liver resection; condyloma; thyroidectorny; thoracotomy; cavernous hemangioma. #### Genitourinary (Urology) The ablation, vaporization, excision, incision, and coagulation of soft tissue in genitourinary (urology) procedures. Applications include: Transurethral: transurethral incision of the prostate (TUIP); bladder {3}------------------------------------------------ 110375 Page 4 ua⑥ tumors; bladder neck incisions; urethral strictures; exterior sphincterotomy. Laparoscopic lymphadenectomy. Open: condyloma; circumcision; benign and malignant lesions of external genitalia ### Thoracic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic surgery including endoscopic and open procedures. Applications include: pulmonary resection; coagulation of blebs and bullae; adhesiolysis; pericardiectorny; mediastinal and thoracic lesions and abnormalities; mediastinal lymph node dissection; hemostasis; thoracotomy. #### Gynecology (GYN) The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include: Laparoscopic excision/lysis of adhesions; endometrial lesions, including ablation of endometriosis; laparoscopic assisted hysterectomy (LAVH); laser uterosacral nerve ablation (LUNA); myomectomy; ovarian cystectomy; ovarian drilling; tubal fimbrioplasty; appendectomy. Open: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN; condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/polyps/adhesions; Resection of septum. ### Pulmonology The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include: tracheal bronchial lesions. #### Ophthalmology The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include: Oculoplastics; open DCR; endonasal DCR; tumor excision and biopsy; eyelid reconstruction; blepharoplasty. #### Orthopedics The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures. Applications include: Open: Dissect and coagulate. ### Otolaryngology (ENT) The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include: Nasal/Sinus: turbinectomy and {4}------------------------------------------------ K110375 Page 5 of 6 turbinate reduction/ablation; polypectorny of nose and nasal passages; ethmoidectorny; meatal antrostomy; Laryngo-tracheal: removal of vocal cord/fold nodules, polyps and cysts;arytenoidectorny; tracheal stenosis; Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectorny (including tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy; Head & Neck: tumor resection on oral, subfacial and neck tissues; parathyroidectorny; thyroidectorny. ### Podiatry Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Matrixectomy Periungual and subungual warts, Plantar warts, Neuromas. The Gold Series is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.). In addition the Blueshine GOLD series Laser is intended for Laser Assisted Lipolysis # Technological Characteristics: The GOLD series Laser is designed with 4 major subsystems: (1) an external structure; (2) power electronics; (3) display with control electronics, which controls the power electronics, the user interface and the laser source temperature via a thermostat board; and (4) the laser system with an opto-mechanical block composed of the laser source, the Peltier cooling system with dissipater and fans, the fiber launching system, the red diode aiming beam, and the power calibration system. The external accessories include separate optical fibers and hand pieces for dental, dermatological and surgical applications, or for endovascular applications. The fiber is connected to the system through an SMA 905 socket on the front panel. In addition to the four subsystems, the Diode Laser Family incorporates several safety features, including a remote interlock and a key switch .. {5}------------------------------------------------ 110375 Page 6 of 6 The Blueshine laser was tested and conformed with the following standards: · IEC 60601-1-1 Ed 2.0 Medical electrical equipment - Part 1-1: General requirements for safety -Collateral standard: Safety requirements for medical electrical systems ● IEC 60601-1-2 Ed 2.1 Medical electrical equipment – Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility -Requirements and tests IEC 60825-1 (2003-2): Safety of laser products - Part 1: ● Equipment classification, requirements and user's guide The Blueshine GOLD series Laser is as safe and effective as the predicate devices. The GOLD series Laser has the same intended uses, and similar indications for use, technological characteristics, and principles of operation as the predicates. The minor # Substantial Equivalence: technological differences between the GOLD series Laser and its predicates raise no new issues of safety or effectiveness. Thus, the GOLD series Laser is substantially equivalent. {6}------------------------------------------------ Image /page/6/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 an abstract symbol that resembles a stylized caduceus or a bird-like figure, composed of three curved lines. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 13, 2013 Blueshine Srl % Ms. Chiara Ricci Via Querini, 27 - 30171 Mestre Venezia, Italy Re: K110375 Trade/Device Name: Blueshine GOLD Series 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: PDZ, GEX Dated: February 23, 2012 Received: February 23, 2012 Dear Ms. Ricci: This letter corrects our substantially equivalent letter of February 23, 2012. 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 {7}------------------------------------------------ Page 2 - Ms. Chiara Ricci 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 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/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 vours. FOR Peter D. Rumm -S Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ # Indications for Use Statement 510(k) Number (if known) : K110375 Blueshine GOLD series Device Name: Indications For Use: Nith. R. Oden Lirata (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices - 510(k) Number K110375 # 980 nm Wavelengths The Blueshine GOLD series , (and the fiber delivery systems and accessories used to deliver laser energy), is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: gastroenterology, neurosurgery, general surgery, genitourinary specialises thoracic surgery, gynecology (GYN), pulmonology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry. The Blueshine GOLD series Laser is indicated for use in the performance of specific surgical applications in gastroenterology, neurosurgery, general surgery, genitourinary surgery (urology), thoracic surgery, gynecology (GYN), pulmonology, ophthalmology, orthopedics, otolaryngology (ENT) and podiatry as follows: # Gastroenterology The ablation, vaporization, excision, incision, and coagulation of soft tissue in The abiation, vaporizations include: hemostasis of esophageal varices; palliation of malignant dysphagia; palliative ablation of obstructive neoplasms; hemostasis of colonoscopy. ### Neurosurgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in I he abization, vaportuations include: tumors adjacent to the spinal cord; tumors adjacent to the cortex. # General Surgery Treatment of varicose veins and varicosities associated with superficial reflux of the greater saphenous vein. The ablation, vaporization, excision, incision, and coagulation of soft tissue in general surgery including endoscopic and open procedures. Coaguiations include: Laparoscopic: appendectomy; cholecystectomy; bowel resection. Applications marador mammoplasty; breast biopsy; rectal and anal Open: "masteotomy; bowel resection; colectory; cholecystectomy; liver resection; condyloma; thyroidectomy; thoracotomy; cavernous hemangioma. # Genitourinary (Urology) The ablation, vaporization, excision, incision, and coagulation of soft tissue in I he ablacions (urology) procedures. Applications include: Transurethral: gentwourmaly (arology) procodate: : 4pp 1020); bladder tumors; bladder neck incisions; {9}------------------------------------------------ urethral strictures; exterior sphincterotomy. Laparoscopic lymphadenectomy. Open: condyloma; circumcision; benign and malignant lesions of external genitalia ## Thoracic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in thoracic I no abouting endoscopic and open procedures. Applications include: pulmonary surestion; coagulation of blebs and bullae; adhesiolysis; pericardiectomy; mediastinal and thoracic lesions and abnormalities; mediastinal lymph node dissection; hemostasis: thoracotomy. ## Gvnecology (GYN) The ablation, vaporization, excision, incision, and coagulation of soft tissue in gynecology (GYN) procedures. Applications include: Laparoscopic excision/lysis of adhesions; endometrial lesions, including ablation of endometriosis; laparoscopic assisted hysterectomy (LAVH); laser uterosacral nerve ablation (LUNA); myomectomy; ovarian cystectomy; ovarian drilling; tubal fimbrioplasty; appendectomy. Open: conization of the cervix, including cervical intraepithelial appenasonal (CIN), vulvar and vaginal intraepithelial neoplasia VIN, VAIN; condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions. Intrauterine: Fibroids/polyps/adhesions; Resection of septum. ### Pulmonology The ablation, vaporization, excision, incision, and coagulation of soft tissue in pulmonology procedures. Applications include: tracheal bronchial lesions. ### Ophthalmology The ablation, vaporization, excision, incision, and coagulation of soft tissue in ophthalmology procedures. Applications include: Oculoplastics; open DCR; endonasal DCR; tumor excision and biopsy; eyelid reconstruction; blepharoplasty. ### Orthovedics The ablation, vaporization, excision, incision, and coagulation of soft tissue in orthopedic surgery procedures. Applications include: Open: Dissect and coagulate. # Otolaryngology (ENT) The ablation, vaporization, excision, incision, and coagulation of soft tissue in otolaryngology procedures. Applications include: Nasal/Sinus: turbinectomy and turbinate reduction/ablation; polypectomy of nose and nasal passages; ethmoidectorny; mestal antrostomy; Laryngo-tracheal: removal of vocal cord/fold nodules, polyps and model unnoidectory; tracheal stenosis; Oropharyngeal: uvulopalatoplasty (LAUP, laser UTPP); tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil; hemi glossectomy; Head & Neck: tumor resection on oral, subfacial and neck tissues; parathyroidectomy; thyroidectomy. :Neffe Dyke fic mxm (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices . 510(k) Number K110375: {10}------------------------------------------------ ### Podiatry Podiatry (ablation, vaporization, incision, excision, and coagulation of soft tissue) including: Matrixectomy Periungual and subungual warts, Plantar warts, Neuromas. The Gold Series is indicated for use for the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.). In addition the Blueshine GOLD series Laser is intended for Laser Assisted Lipolysis Prescription Use: _ X (Part 21 C.F.R. 801 Subpart D) AND/OR Over-The-Counter Use: (Part 21 C.F.R. 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Blueshine srl via Querini,27 30171, Mestre Venezia Italy Contact person Chiara Ricci CEO +390415055847 blueshine@blueshine.biz Neil R.P. Ogden for mxm (Division Sign-Off) (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K110375