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 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 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

Device Description

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that demonstrates the Blueshine's GOLD series device meets those criteria, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) summary does not explicitly state pre-defined acceptance criteria in terms of numerical thresholds for device performance. Instead, it presents the "results" of a clinical study, implying these outcomes are considered acceptable for demonstrating the safety and effectiveness of the device for onychomycosis treatment.

Criterion (Implicit)	Reported Device Performance
Efficacy in treating Onychomycosis (Overall Improvement)	- 93.75% of treated nails improved by at least 1/3 of the nail plate. - No nails worsened. - 6.25% of nails were unchanged.
Efficacy in treating Onychomycosis (Complete Clearing)	- 77.09% (37 out of 48) of eligible toenails showed complete clear nails (improvement > 2/3). - 17% (8 out of 48) showed middle clear (improvement 1/3 to 2/3).
Safety	"The procedure is simple and quick with no noticeable side effects and complications." (This statement acts as the reported safety performance, implying an acceptance criterion of "no noticeable side effects and complications.")

2. Sample Size Used for the Test Set and Data Provenance

Sample Size (Test Set): 48 patients with onychomycosis. The study specifically followed 48 treated nails.
Data Provenance: The study was conducted in "Two private practices in Padua and Venice, Italy." This indicates the data is prospective (a follow-up study was conducted) and originates from Italy.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for the test set. It mentions that "All nails are checked visually and classified," but does not specify who performed this visual check or their credentials.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It only states that nails were "checked visually and classified." This suggests a single reviewer or a non-adjudicated consensus, but without more detail, it's impossible to be certain.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a single-arm follow-up study on the performance of the Blueshine's GOLD series laser treatment; it does not compare human readers' performance with and without AI assistance, nor does it involve multiple readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable, as the device is a laser surgical instrument, not an AI algorithm. The performance described is the direct clinical outcome of the laser treatment on patients, administered by a human.

7. Type of Ground Truth Used

The ground truth used for evaluating the device's efficacy was based on visual assessment and classification of nail improvement.
The classifications were:

Unchanged (< 1/3 improvement)
Middle cleared (1/3 to 2/3 improvement)
Completely cleared (> 2/3 improvement)

This is a clinical expert assessment, but the specific expert qualifications are not detailed.

8. Sample Size for the Training Set

This information is not applicable. The device is a medical device (laser instrument), not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "training" for such a device would typically refer to the clinical studies and engineering development that lead to its final design and parameters, rather than a data-driven training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no "training set" in the context of an AI algorithm. For a physical device, ground truth establishment would refer to the validation of its design and operational parameters through testing and clinical trials, but not in the sense of a machine learning model.

Summary

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Title:

510(k) SUMMARY Blueshine's GOLD series

FEB 2 3 202

Submitter:	Blueshine srl via Querini,27 30171, Mestre VeneziaItalyContact person Chiara Ricci CEO+390415055847blueshine@blueshine.biz
Contact:	Chiara RicciC.E.O.
Date Prepared:	Dec. 01, 2011
Device Trade Name:	Blueshine's GOLD series
Common Name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology
ClassificationName:	Instrument, surgical, powered, laserGEX21 C.F.R. 878.4810
Predicate Devices:	• Quanta System S.p.A. Diode Medical LaserFamily (K072034)• Osyris, Pharaon Lipo (K073617)• Pinpointe, Pinpointe Footlaser (K093547)
Summary ofOnychomycosisClinical data	Abstract: A 6-month follow-up study was conducted on48 patients who received laser treatment foronychomycosis with Gold Series 980 Diode Laser(BlueShine, Venice - Italy).Objective To examine long-term cure and relapse ratesafter treatment with a 2 millisecond-pulse 980 nm near-infrared laser in onychomycosis.Setting Two private practices in Padua and Venice, Italy.Subjects & Methods The study population comprised 48patients (31 male & 17 female) aged 23 to 79 years with aclinical and mycological diagnosis of onychomycosis.The Laser treatment consisted of 3 /4 sessions with 30days interval. Each nail was treated with 2 alternatingpasses of laser pulses to cover the full nail, one passapplied vertically down each nail and the second applied

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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:
1. Middle cleared means that the improvement was 1/3 to 2/3:
1. completely cleared means that the improvement was > 2/3.

Results
Unchanged	3 (6%)
Middle clear	8 (17%)
Complete clear	37 (77%)
Total	48 (100%)

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Intended Use / Indications for Use:

980nm Wavelengths

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

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110375
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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

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K110375
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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:

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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.

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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

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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

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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;

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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

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:

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Podiatry

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

Regulation Number and Section

§ 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.