REVOLIX DUO LASER SYSTEM

{0}------------------------------------------------ K070466 # Attachment V # 510(k) Summary APR 1 7 2007 ### 1.General Information | Submitter: | AllMed Systems Inc.<br>9232 Klemetson Drive<br>Pleasanton CA 94588 | |----------------|--------------------------------------------------------------------| | Phone: | 925-468-0433 | | Fax: | 925-399-5984 | | Contact Person | Peter Allen | | Date Prepared | 16th February 2007 | - 2. Names | Device Name | Revolix Duo Laser System | |---------------------|-------------------------------------------| | Common Name | 2.01micron and 2.1 micron Laser System | | Classification Name | Laser Surgical Instrument and accessories | ## 3. Predicate Device Lisa Laser Products – RevoLix Continous Wave 2 micron Laser Lisa Laser Products - Sphinx 80 Watt Holmium Laser System # 4. Product Description The RevoLix Duo is a combination of a diode pump solid state laser operating at a wavelength of 2.01 micron and a pulsed flashlamp Holmium laser operating at 2.1 microns. The purpose of the laser is the ablation, coagulation, dissection and resection of soft tissue. The laser is designed for open surgery and surgical applications in aqueous media. The laser power is delivered via standard silica laser fibers. The distal tip is guided by a handpiece or endoscopic surgical instrument. {1}------------------------------------------------ It consists of: Laser Console with Internal Computer Control Panel and Display A fiber optic delivery system Footswitch #### 5. Indications for Use The Revolix Duo continuous wave 2.01 micron laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery # Continuous Wave 2.01 micron Laser ### Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors. Ablation of Benign Prostatic Hyperplasia (BHP). Transurethral incision of the prostate (TUIP) Holmium Laser Resection of the Prostrate (HoLRP) Holmium Laser Enuculeation of the Prostate (HoLEP) Holmium laser Ablation of the Prostate (HoLAP) Condylomas Lesions of external genitalia ## Gasteroenterlogy Open and endoscopic gasteroenterlogy surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: - Appendectomy Polyps Biopsv Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy {2}------------------------------------------------ Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions ## Thoracic and Pulmonary Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue Laryngeal Lesions Airway obstructions including carcinoma Polyps and Granuloma Palliation of obstructing carcinoma of the tracheobroncial tree #### Gynecology Open and faparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) Intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision and or vessel coagulation Soft tissue excision procedures such as excisional conization of the cervix ## ENT Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including: > Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Lesions or tumors of the oral, nasal, glossal, pharyngeal or laryngeal Tonsillectomy Adenoidectomy {3}------------------------------------------------ # Dermatology and Plastic Surgery Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts #### General Surgery Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Cholecystectomy Lysis of adhesion Appendectomy Biopsy Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs, tumors and lesions Mastectomy Hepatectomy Pancreatectomy Splenectomy Thyroidectomy Parathyroidectomy Herniorrhaphy Tonsillectomv Lymphadenectomy Partial Nephrectomy Pilonidal Cystectomy Resection of lipoma Debridement of Decubitus Ulcer Hemorrhoids Debridement of Statis Ulcer Biopsy #### Arthroscopy Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) > Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including Percutaneous Laser Disc Decompression/Discectomy Foraminoplasty {4}------------------------------------------------ Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery. The Revolix Duo pulsed Holmium 2.1 micron laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue in use in medical specialties including: Urnlogy, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery. ## Holmium Laser pulsed 2.1 micron #### Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors. Ablation of Benign Prostatic Hypertrophy (BHP), Transurethral incision of the prostate (TUIP) Holmium Laser Resection of the Prostrate (HoLRP) Holmium Laser Enuculeation of the Prostate (HoLEP) Holmium laser Ablation of the Prostate (HoLAP) Condvlomas Lesions of external genitalia Lithotripsy and Percutaneous Urinary Lithotripsy Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones. Endoscopic fragmentation of kidney calculi Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed. #### Gastroenterology Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: Appendectomy Polyps Biopsy Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers {5}------------------------------------------------ Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophaqitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions ### Arthroscopy Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including: Ligament and tendon Release Contouring and sculpting of articular surfaces Capsulectomy in the Knee Chondreplasty in the Knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears Plica Removal Meniscectomy Loose Body Debridement Lateral retinecular release Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy ## Pulmonary Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) {6}------------------------------------------------ ## Gynecology Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue ## ENT Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including: Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery #### Dermatology and Plastic Surgery Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas #### General Surgery Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete of partial resection of internal organs, tumors and lesions Biopsv # 6. Rationale for Substantial Equivalence The Revolix Duo laser system with fiber optic delivery devices share the same intended use, indications for use, similar design features and functional features and therefore are {7}------------------------------------------------ substantially equivalent to the Lisa Laser Products RevoLix continuous wave 2 micron laser , and the Lisa Laser Products Sphinx 80 watt Holmium Laser # 7. Conclusion .. The Revolix Duo Laser System with fiber optic delivery devices were found to be substantially equivalent to similar currently marketed and predicate surgical laser systems and delivery devices. {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol. #### Public Health Service Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 AllMed Systems, Inc. % Mr. Peter Allen President 9232 Klemetson Drive Pleasanton, California 94588 Re: K070466 Trade/Device Name: Revolix Duo Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: April 6, 2007 Received: April 9, 2007 APR 1 7 2007 Dear Mr. Allen: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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. {9}------------------------------------------------ Page 2 -- Mr. Peter Allen This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark N. Melkerson Mark N. Aelkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ 510(k) Number: Device Name: Revolix Duo Indications For Use: The Revolix Duo continuous wave 2.01 micron laser system and its fiber optic delivery system are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gasteroenterology, Arthroscopy, Discetomy, Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery #### Continuous Wave 2.01 micron Laser #### Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors. Ablation of Benign Prostatic Hyperplasia (BHP), Transurethral incision of the prostate (TUIP) Holmium Laser Resection of the Prostrate (HoLRP) Holmium Laser Enuculeation of the Prostate (HoLEP) Holmium laser Ablation of the Prostate (HoLAP) Condylomas Lesions of external genitalia #### Gasteroenterlogy Open and endoscopic gasteroenterlogy surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: Appendectomy Polyps Biopsv Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 1 of 9 {11}------------------------------------------------ 510(k) Number: Device Name: Revolix Duo Indications For Use: Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenal ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions #### Thoracic and Pulmonary Open and endoscopic thoracic and pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue Larvngeal Lesions Airway obstructions including carcinoma Polyps and Granuloma Palliation of obstructing carcinoma of the tracheobroncial tree Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 2 of 9 {12}------------------------------------------------ 510(k) Number: Device Name: Revolix Duo Indications For Use: ### Gynecology Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) Intra-uterine treatment of submucous fibroids, benign endometrial polyps, and uterine septum by incision, excision and or vessel coagulation Soft tissue excision procedures such as excisional conization of the cervix ## ENT Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) including: > Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomv Functional endoscopic sinus surgery Lesions or tumors of the oral, nasal, glossal, pharyngeal or laryngeal Tonsillectomy Adenoidectomy ## Dermatology and Plastic Surgery Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Basal Cell Carcinomas Lesions of skin and subcutaneous tissue AND/OR Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 3 of 9 {13}------------------------------------------------ 510(k) Number: Device Name: Revolix Duo Indications For Use: ### Skin tags Plantar warts ### General Surgery Open laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Cholecystectomy Lysis of adhesion Appendectomy Biopsy Skin incision Tissue dissection Excision of external tumors and lesions Complete or partial resection of internal organs, tumors and lesions Mastectomy Hepatectomy Pancreatectomy Splenectomy Thyroidectomy Parathyroidectomy Herniorrhaphy Tonsillectomy Lymphadenectomy Partial Nephrectomy Pilonidal Cystectomy Resection of lipoma Debridement of Decubitus Ulcer Hemorrhoids Debridement of Statis Ulcer Biopsy Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 4 of 9 {14}------------------------------------------------ 510(k) Number: Device Name: Revolix Duo Indications For Use: Arthroscopy Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) > Ablation of soft and cartilaginous tissue in Minimal Invasive Spinal Surgery including Percutaneous Laser Disc Decompression/Discectomy Foraminoplastv Ablation and coagulation of soft vascular and non vascular tissue in minimally invasive spinal surgery. The Revolix Duo pulsed Holmium 2.1 micron laser system and its fiber optic delivery system are intended for use in surgical procedures using open, faparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft and hard tissue in use in medical specialties including: Urology, Urinary Lithotripsy, Gastroenterology, Arthroscopy, Discetomy Pulmonary, Gynecology, ENT, Dermatology, Plastic Surgery and General Surgery. #### Holmium Laser pulsed 2.1 micron #### Urology Open and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Urethral Strictures Bladder Neck Incisions (BNI) Ablation and resection of Bladder Tumors, Uretheral Tumors and Ureteral Tumors. Ablation of Benign Prostatic Hypertrophy (BHP), Transurethral incision of the prostate (TUIP) Holmium Laser Resection of the Prostrate (HoLRP) Prescription Use X AND/OR (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 5 of 9 {15}------------------------------------------------ 510(k) Number: Device Name: Revolix Duo Indications For Use: Holmium Laser Enuculeation of the Prostate (HoLEP) Holmium laser Ablation of the Prostate (HoLAP) Condylomas Lesions of external genitalia Lithotripsy and Percutaneous Urinary Lithotripsy Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones. Endoscopic fragmentation of kidney calculi Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed. ### Gastroenterology Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis ) including: Appendectomy Polyps Biopsv Gall Bladder calculi Biliary/Bile duct calculi Ulcers Gastric ulcers Duodenai ulcers Non Bleeding Ulcers Pancreatitas Hemorrhoids Cholecystectomy Benign and Malignant Neoplasm Angiodysplasia Colorectal cancer Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) AND/OR Concurrence of CDRH, Office of Device Evaluation (ODE) Page 6 of 9 {16}------------------------------------------------ # 510(k) Number: Device Name: Revolix Duo Indications For Use: Telangiectasias Telangiectasias of the Osler-Weber-Renu disease Vascular Malformation Gastritis Esophagitis Esophageal ulcers Varices Colitis Mallory-Weiss tear Gastric Erosions #### Arthroscopy Arthroscopy/Orthopedic surgery (excision, ablation and coagulation of soft and cartilaginous tissue) in small and large joints of the body, excluding the spine but including: Ligament and tendon Release Contouring and sculpting of articular surfaces Capsulectomy in the Knee Chondreplasty in the Knee Debridement of inflamed synovial tissue Chondromalacia Ablation Chondromalacia and tears Plica Removal Meniscectomy Loose Body Debridement Lateral retinecular release Ablation of soft, cartilaginous and bony tissue in Minimal Invasive Spinal Surgery including Percutaneous Laser Disc Decompression/Discectomy of the L4-5 and L5-S1 lumbar discs, including Foraminoplasty Percutaneous Cervical Disc Decompression/Discectomy Percutaneous Thoracic Disc Decompression/Discectomy | Prescription Use<br>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 CDRH, Office of Device Evaluation (ODE) Page 7 of 9 {17}------------------------------------------------ 510(k) Number: Device Name: Revolix Duo Indications For Use: #### Pulmonary Open and endoscopic pulmonary surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue) #### Gynecology Open and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue #### ENT Endoscopic endonasal surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue and cartilage) including: Endonasal/sinus Surgery Partial turbinectomy Polypectomy Dacryocystorhinostomy Frontal Sinusotomy Ethmoidectomy Maxillary antrostomy Functional endoscopic sinus surgery Dermatology and Plastic Surgery Incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft, mucosal, fatty and cartilaginous tissue, in therapeutic plastic, dermatologic and aesthetic surgical procedures including: Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 8 of 9 {18}------------------------------------------------ 510(k) Number: Device Name: Revolix Duo Indications For Use: Basal Cell Carcinomas Lesions of skin and subcutaneous tissue Skin tags Plantar warts Lesions of skin and subcutaneous tissue Port Wine Stains Papillomas #### General Surgery Open, laparoscopic and endoscopic surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including: Appendectomy Skin incision Excision of external and internal lesions Complete of partial resection of internal organs, tumors and lesions Biopsy (Division Sign-Off) Division of General, Restorative, and Neurological Devices **510(k) Number** k070466 Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Page 9 of 9