(89 days)
Not Found
No
The summary describes a laser system for soft tissue ablation and excision, controlled by a computer, but there is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is indicated for a wide range of surgical applications involving the ablation, vaporization, excision, incision, and coagulation of soft tissue, including the treatment of various medical conditions and diseases across multiple specialties such as dermatology, podiatry, gynecology, neurosurgery, and orthopedics. This directly aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No.
The device's intended use and indications for use describe surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue, primarily for treatment purposes, not for diagnosis.
No
The device description explicitly states that the Syneron CO2RE is a "computer controlled radio-frequency (RF) excited carbon dioxide (CO2) laser system" comprised of "multiple components, including the control unit and three handpieces (standard, fractional and surgical)." This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the CO2RE device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CO2RE Intended Use: The CO2RE's intended use is clearly described as a surgical laser system for the ablation, vaporization, excision, incision, and coagulation of soft tissue in various medical specialties. It directly interacts with and modifies human tissue in vivo (within the living body).
- No Specimen Analysis: The description does not mention any collection, preparation, or analysis of specimens taken from the body. The device's function is to deliver laser energy to the target tissue.
Therefore, the CO2RE is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CO2RE is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including; aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee),
The CO2RE is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
The Standard Handpiece of the CO2RE System is indicated for the following:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- laser skin resurfacing .
- laser dermabrasion
- . laser burn debridement.
Laser skin resurfacing (ablation and/or vaporization) for the treatment of:
wrinkles, rhytids, and furrows (including fines and texture irregularities) . Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, . seborrheic wart, and verruca seborrheica;
- . vermillionectomy of the lip;
- cutaneous horns;
- solar/actinic elastosis; ●
- chelitis, including actinic chelitis; ●
- lentigines, including lentigo maligna or Hutchinson's malignant freckle
- uneven pigmentation/ dyschromia;
- acne scars;
- surgical scars: ●
- keloids including acne keloidalis nuchae;
- . hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum);
- . tattoos;
- telangiectasia;
- removal of small skin tumors, including periungual (Koenen) and subungual fibromas; ●
- superficial pigmented lesions: .
- adenosebaceous hypertrophy or sebaceous hyperplasia; .
- . rhinophyma reduction;
- cutaneous papilloma (skin tags):
- milia:
- . debridement of eczematous or infected skin;
- basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions;
- nevi, including spider, epidermal and protruding;
- neurofibromas:
- laser de-epithelialization: .
- tricoepitheliomas;
- xanthelasma palpebrarum; ●
- . svringoma
Laser ablation, vaporization and for excision for complete or partial nail matrixectomy. Vaporization/coagulation of:
- benign/malignant vascular/avascular skin lesions; .
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts.
Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:
. verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts;
- . fungal nail treatment;
- porokeratoma ablation:
- ● ingrown nail treatment;
- neuromas/fibromas, including Morton's neuroma: ●
- debridement of ulcers;
- other soft tissue lesions. .
Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
● leukoplakia, including oral, larynx, uvula, palatal, upper latera pharyngeal tissue;
- nasal obstruction: ●
- adult and juvenile papillomatosis polyps;
- polypectomy of nose and nasal passages; ●
- lymphangioma removal; ●
. removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tonque and vocal cords;
● superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease; - rhinophvma:
- verrucae vulgares (warts);
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:
. conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
condyloma acuminate, including cervical, genital, vulvar, perineal, and ● Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;
- . leukoplakia (vulvar dystrophies);
- herpes vaporization; ●
- urethral caruncle vaporization; ●
- . cervical dysplasia:
- benign and malignant tumors; ●
Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- treatment of ulcerous lesions, including aphthous ulcers; ●
- excision and ablation of benign and malignant lesions; ●
- leukoplakia;
Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:
- benign and malignant lesions of external genitalia; ●
- condyloma:
- erythroplasia ●
The Fractional Handpiece of the CO2RE System is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
The Surgical Handpiece of the CO2RE System is indicated for the following:
Dermatology & Plastic Surgery
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- . vermillionectomy of the lip;
- cutaneous horns:
- removal of small skin tumors, including periungual (Koenen) and subungual fibromas; ●
- . rhinophyma reduction;
- basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease . (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions:
- . neurofibromas:
Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of:
- benign/malignant vascular/avascular skin lesions; .
- . Moh's Surgery;
- Lipectomy; .
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and ● subunqual warts.
Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.
Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:
- . verrucae vulgares/plantar (warts), including paronychial, periungal, and subunqual warts:
Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
- choanal atresia,
- nasal obstruction:
- adult and juvenile papillomatosis polyps;
- polypectomy of nose and nasal passages;
- lymphangioma removal; ●
- removal of vocal cord/fold nodules, polyps and cysts;
- . removal of recurrent papillomas in the oral cavity, nasal cavity, larynx,
pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;
. laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue;
Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-● assisted esophaqodivertuculostomy (ELAED)]; - stenosis, including subglottic stenosis;
● tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy; - pulmonary bronchial and tracheal lesion removal;
benign and malignant nodules, tumors and fibromas (larynx, pharynx, ● trachea, tracheobronchial/endobronchial); - benign and malignant lesions and fibromas (nose and nasal passages);
- benign and malignant tumors and fibromas (oral);
- stapedotomy/stapedectomy:
- acoustic neuroma in the ear;
. superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease;
telangiectasia/hemangioma of larynx, pharynx and trachea (includes ● uvula, palatal or upper lateral pharyngeal tissue);
cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal ● fold motion impairment), and cordal lesions of larynx, pharynx and trachea; - myringotomy/tympanostomy (tympanic membrane fenestration);
- uvulopalatoplasty (LAUP, laser UPPP);
- turbinectomy and turbinate reduction/ablation;
- septal spur ablation/reduction and septoplasty; ●
- partial glossectomy;
- tumor resection on oral, subfacial and neck tissues;
- rhinophyma:
- verrucae vulgares (warts); ●
- gingivoplasty/gingivoctomy.
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:
conization of the cervix, including cervical intraepithelial neoplasia (CIN), ● vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
condyloma acuminate, including cervical, genital, vulvar, perineal, and ● Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;
- . incision and drainage (I&D) of Bartholin's and nubuthian cysts;
- benign and malignant tumors;
- hemangiomas.
GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:
- endometrial lesions, including ablation of endometriosis; ●
- excision/lysis of adhesions; ●
- salpingostomy
- oophorectomy/ovariectomy: ●
- fimbrioplasty;
- metroplasty;
- microsurgery (tubal);
- uterine myomas and fibroids;
- ovarian fibromas and follicle cysts: ●
- uterosacral ligament ablation;
- hysterectomy.
Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of:
Cranial
- posterior fossa tumors;
- peripheral neurectomy; ●
- benign and malignant tumors and cysts (e.g. gliomas, menigiomas (including ● basal tumors), acoustic neuromas, lipomas and large tumors);
- arteriovenous malformation;
- pituitary gland tumors (transphenoidal approach). .
Spinal Cord
incision/excision and vaporization of benign and malignant tumors and ● cysts:
- intra- and extradural lesions;
- laminectomy/ laminotomy/ microdiscectomy. ●
Orthopedics
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:
Arthroscopy .
- menisectomy;
- chondromalacia;
- . chondroplasty:
- ligament release (lateral and other);
- excision of plica; ●
- partial synovectomy.
General
- debridement of traumatic wounds; ●
- debridement of decubitus and diabetic ulcers; ●
- microsurgery;
- artificial joint revision; ●
- PMMA removal.
General/Thoracic Surgery
Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:
- debridement of decubitus ulcers, stasis, diabetic and other ulcers; ●
- mastectomy;
- debridement of bums;
- rectal and anal hemorrhoidectomy;
- breast biopsy;
- reduction mammoplasty;
- cytoreduction for metastatic disease;
- . laparotomy and laparoscopic applications;
- mediastinal and thoracic lesions and abnormalities: ●
- skin tag vaporization;
- atheroma:
- cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips;
- pilonidal cyst removal and repair;
- abscesses;
- other soft tissue applications.
Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- gingivectomy- removal of hyperplasias;
- . qinqivoplasty:
- incisional and excisional biopsy;
- incision of infection when used with antibiotic therapy; ●
- frenectomy (frenum release);
- excision and ablation of benign and malignant lesions: ●
- homeostasis;
- operculectomy;
- crown lengthening:
- removal of soft tissue, cysts and tumors;
- . oral cavity tumors and hemangiomas:
- abscesses:
- extraction site hemostasis;
- salivary gland pathologies;
- preprosthetic gum preparation; ●
- . partial glossectomy;
- periodontal gum resection.
Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:
- benign and malignant lesions of external genitalia; ●
- condyloma; ●
- Phimosis:
- Erythroplasia.
Product codes
GEX
Device Description
The Syneron CO2RE is a computer controlled radio-frequency (RF) excited carbon dioxide (CO2) laser system that delivers CO2 energy to the target treatment area at 10,600 nm. The Syneron CO2RE is comprised of multiple components, including the control unit and three handpieces (standard, fractional and surgical). Laser is transmitted to the tissue via a series of lenses integrated into the articulated arm. The CO2 laser energy is absorbed by water in tissue to achieve its intended treatment effects.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, skin, lips, nails/nail matrix, ear, nasal cavity, larynx, pharynx, trachea, vocal cords, tongue, cervix, vulva, vagina, perineum, external genitalia, oral cavity, oral structures, jaw, nose, eye area (eyelids), hair follicles, uterus, ovaries, ligaments, brain (posterior fossa, pituitary gland), spinal cord, peripheral nerves, joints (knee), wounds, breast, rectum, anus, mediastinum, chest, salivary glands.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software: Verification and validation testing of the software confirm that the software version is appropriate for release.
Electrical Safety and Electromagnetic Compatibility: The CO2RE System has been tested for electromagnetic compatibility and electrical safety per the applicable recognized consensus standards (IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-22). Results were passing.
Biocompatibility: Biocompatibility of the patient contacting components of the device has been established per FDA's quidelines.
Sterilization: Sterilization parameters have been validated.
Performance Data: Histological analysis has been performed to evaluate the device effects across a range of treatment parameters.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a black and white 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, with three intertwined strands and three human profiles facing right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 15, 2015
Syneron Medical Ltd. % Ms. Janice M. Hogan Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103
Re: K151655
Trade/Device Name: Syneron CO2RE Laser System 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: June 18, 2015 Received: June 18, 2015
Dear Ms. Hogan:
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
1
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 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/Resourcesfor You/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 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 yours,
Joshua C. Mipper -S
Binita S. Ashar, M.D., M.B.A., F.A.C.S.
For Director
Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
K151655
Device Name
Syneron CO2RE Laser System
Indications for Use (Describe)
The CO2RE is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including; aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee).
The CO2RE is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
The Standard Handpiece of the CO2RE System is indicated for the following:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- laser skin resurfacing
- laser dermabrasion ●
- o laser burn debridement.
Laser skin resurfacing (ablation and/or vaporization) for the treatment of:
wrinkles, rhytids, and furrows (including fines and texture irregularities) o Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, seborrheic wart, and verruca seborrheica;
- vermillionectomy of the lip;
- cutaneous horns;
- solar/actinic elastosis:
- chelitis, including actinic chelitis;
- lentigines, including lentigo maligna or Hutchinson's malignant freckle
- uneven pigmentation/ dyschromia;
- acne scars;
- surgical scars;
- keloids including acne keloidalis nuchae:
- hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma ● pyogenicum/granuloma telagiectaticum);
- tattoos:
3
- telangiectasia: ●
- removal of small skin tumors, including periungual (Koenen) and subungual fibromas; ●
- superficial pigmented lesions;
- adenosebaceous hypertrophy or sebaceous hyperplasia; ●
- rhinophyma reduction;
- cutaneous papilloma (skin tags);
- milia:
- debridement of eczematous or infected skin;
- basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions;
- nevi, including spider, epidermal and protruding;
- . neurofibromas:
- laser de-epithelialization; ●
- o tricoepitheliomas;
- . xanthelasma palpebrarum;
- . svringoma
Laser ablation, vaporization and /or excision for complete or partial nail matrixectorny.
Vaporization/coagulation of:
- benign/malignant vascular/avascular skin lesions;
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts.
Podiatrv
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:
• verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts;
- · fungal nail treatment;
- · porokeratoma ablation;
- · ingrown nail treatment;
- · neuromas/fibromas, including Morton's neuroma;
- debridement of ulcers:
- · other soft tissue lesions.
Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
- · leukoplakia, including oral, larynx, uvula, palatal, upper latera pharyngeal tissue;
- nasal obstruction;
- · adult and juvenile papillomatosis polyps;
- polypectomy of nose and nasal passages;
- lymphanqioma removal;
· removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;
• superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease;
- rhinophyma;
- · verrucae vulgares (warts);
4
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in avnecology (GYN) for the treatment of:
- · conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
- · condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;
- · leukoplakia (vulvar dystrophies);
- · herpes vaporization:
- · urethral caruncle vaporization;
- · cervical dysplasia;
- benign and malignant tumors;
Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- · treatment of ulcerous lesions, including aphthous ulcers;
- · excision and ablation of benign and malignant lesions;
- leukoplakia;
Genitourinarv
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:
- · benign and malignant lesions of external genitalia;
- condyloma:
- erythroplasia
The Fractional Handbiece of the CO-RE System is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
The Surgical Handpiece of the CO2RE System is indicated for the following:
Dermatology & Plastic Surgerv
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- vermillionectomy of the lip;
- cutaneous horns: ●
- . removal of small skin tumors, including periungual (Koenen) and subunqual fibromas;
- rhinophyma reduction;
- basal and squamous cell carcinoma, including keratoacanthomas. Bowen's disease . (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions:
- neurofibromas: ●
Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of:
- benign/malignant vascular/avascular skin lesions; ●
- Moh's Surgery; ●
- Lipectomy;
Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts. o Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.
5
Podiatrv
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:
• verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts:
Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
- · choanal atresia,
- nasal obstruction;
- · adult and juvenile papillomatosis polyps;
- polypectomy of nose and nasal passages;
- · Ivmphangioma removal:
- · removal of vocal cord/fold nodules, polyps and cysts;
• removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;
-
laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue;
• Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-assisted esophagodivertuculostomy (ELAED)]; -
· stenosis, including subglottic stenosis;
-
tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy;
-
· pulmonary bronchial and tracheal lesion removal;
• benign and malignant nodules, tumors and fibromas (larvnx, pharvnx, trachea. tracheobronchial/endobronchial);
- · benign and malignant lesions and fibromas (nose and nasal passages);
- · benign and maliqnant tumors and fibromas (oral);
- · stapedotomy/stapedectomy;
- acoustic neuroma in the ear;
- superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease;
• telangiectasia/hemanqioma of larynx, pharynx and trachea (includes uvula, palatal or upper lateral pharyngeal tissue);
· cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea;
- · myringotomy/tympanostomy (tympanic membrane fenestration);
- · uvulopalatoplasty (LAUP, laser UPPP);
- · turbinectomy and turbinate reduction/ablation:
- · septal spur ablation/reduction and septoplasty;
- · partial glossectomy;
- · tumor resection on oral, subfacial and neck tissues;
- rhinophyma;
- · verrucae vulgares (warts);
- · gingivoplasty/gingivoctomy.
6
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:
- conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
- · condyloma acuminate, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;
- · incision and drainage (I&D) of Bartholin's and nubuthian cysts;
- · benign and malignant tumors:
- · hemangiomas.
GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:
- · endometrial lesions, including ablation of endometriosis;
- · excision/lysis of adhesions;
- · salpingostomy
- oophorectomy/ovariectomy;
- · fimbrioplasty;
- · metroplasty:
- · microsurgery (tubal);
- · uterine myomas and fibroids;
- · ovarian fibromas and follicle cysts;
- · uterosacral ligament ablation;
- hysterectomy.
Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of:
Cranial
- posterior fossa tumors;
- · peripheral neurectomy;
- benign and malignant tumors and cysts (e.g. gliomas, menigiomas (including basal tumors), acoustic neuromas, lipomas and large tumors);
- · arteriovenous malformation;
· pituitary gland tumors (transphenoidal approach).
Spinal Cord
- · incision/excision and vaporization of benign and malignant tumors and cysts;
- · intra- and extradural lesions;
- · laminectomy/ laminotomy/ microdiscectomy.
Orthopedics
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include: Arthroscopy
- · menisectomy:
- · chondromalacia;
- chondroplasty;
- · ligament release (lateral and other);
- · excision of plica;
- partial synovectomy.
7
General
- · debridement of traumatic wounds;
- · debridement of decubitus and diabetic ulcers;
- · microsurgery;
- · artificial joint revision;
- PMMA removal.
General/Thoracic Surgery
Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:
- · debridement of decubitus ulcers, stasis, diabetic and other ulcers;
- · mastectomy;
- debridement of bums;
- · rectal and anal hemorrhoidectomy;
- · breast biopsy;
- · reduction mammoplasty;
- · cytoreduction for metastatic disease;
- · laparotomy and laparoscopic applications;
- · mediastinal and thoracic lesions and abnormalities;
- · skin tag vaporization;
- · atheroma;
- · cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips;
- · pilonidal cyst removal and repair;
- abscesses;
- other soft tissue applications.
Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- · gingivectomy- removal of hyperplasias;
- · gingivoplasty;
- · incisional and excisional biopsy;
- · incision of infection when used with antibiotic therapy;
- · frenectomy (frenum release);
- · excision and ablation of benign and malignant lesions;
- · homeostasis;
- · operculectomy:
- · crown lengthening;
- · removal of soft tissue, cysts and tumors;
- oral cavity tumors and hemangiomas;
- abscesses;
- · extraction site hemostasis;
- salivary gland pathologies;
- · preprosthetic qum preparation;
- · partial glossectomy;
- · periodontal gum resection.
8
Page 7 of 7
Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:
- · benign and malignant lesions of external genitalia;
- condyloma:
- Phimosis;
- · Erythroplasia.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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.
9
510(k) SUMMARY
Syneron Medical Ltd.'s CO2RE System
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Syneron Medical Ltd. P.O.B. 550 Industrial Zone Tavor Building Yokneam Illit, 20692 Israel
Phone: 972-73-244-2200 Facsimile: 972-73-244-2202
Contact Person: Ruthie Amir, MD, Global Vice President of Clinical, Regulatory and Education
Date Prepared: September 14, 2015
Name of Device
Syneron CO2RE System
Common or Usual Name
Laser surgical instrument for use in general and plastic surgery and in dermatology
Classification
21 CFR 878.4810, Class II, product code GEX
Predicate Devices
Alma Lasers, Inc.'s Pixel CO2 Laser System (K103501) (Primary Predicate), Syneron Medical Ltd.'s eMatrix CO2 (K101321)
Intended Use / Indications for Use
The CO>RE is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including; aesthetic surgery (dermatology and plastic surgery), podiatry, gynecology, neurosurgery, orthopedics (soft tissue), arthroscopy (knee),
The CO-RE is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
The Standard Handpiece of the COJRE System is indicated for the following:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
- laser skin resurfacing .
10
- laser dermabrasion
- . laser burn debridement.
Laser skin resurfacing (ablation and/or vaporization) for the treatment of:
wrinkles, rhytids, and furrows (including fines and texture irregularities) . Clinical literature demonstrates that skin resurfacing of wrinkles, rhytids, and furrows with CO2 laser increases the amount of sub-epidermal collagen.
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- keratoses, including actinic and seborrheic keratosis, seborrhoecae vulgares, . seborrheic wart, and verruca seborrheica;
- . vermillionectomy of the lip;
- cutaneous horns;
- solar/actinic elastosis; ●
- chelitis, including actinic chelitis; ●
- lentigines, including lentigo maligna or Hutchinson's malignant freckle
- uneven pigmentation/ dyschromia;
- acne scars;
- surgical scars: ●
- keloids including acne keloidalis nuchae;
- . hemangiomas (including Buccal, port wine and pyogenic granulomas/granuloma pyogenicum/granuloma telagiectaticum);
- . tattoos;
- telangiectasia;
- removal of small skin tumors, including periungual (Koenen) and subungual fibromas; ●
- superficial pigmented lesions: .
- adenosebaceous hypertrophy or sebaceous hyperplasia; .
- . rhinophyma reduction;
- cutaneous papilloma (skin tags):
- milia:
- . debridement of eczematous or infected skin;
- basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions;
- nevi, including spider, epidermal and protruding;
- neurofibromas:
- laser de-epithelialization: .
- tricoepitheliomas;
- xanthelasma palpebrarum; ●
- . svringoma
Laser ablation, vaporization and for excision for complete or partial nail matrixectomy. Vaporization/coagulation of:
- benign/malignant vascular/avascular skin lesions; .
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and subungual warts.
Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:
. verrucae vulgares/plantar (warts), including paronychial, periungal, and subungual warts;
- . fungal nail treatment;
K151655 Page 2 of 8
11
- porokeratoma ablation:
- ● ingrown nail treatment;
- neuromas/fibromas, including Morton's neuroma: ●
- debridement of ulcers;
- other soft tissue lesions. .
Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
● leukoplakia, including oral, larynx, uvula, palatal, upper latera pharyngeal tissue;
- nasal obstruction: ●
- adult and juvenile papillomatosis polyps;
- polypectomy of nose and nasal passages; ●
- lymphangioma removal; ●
. removal of recurrent papillomas in the oral cavity, nasal cavity, larynx, pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tonque and vocal cords;
● superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease;
- rhinophvma:
- verrucae vulgares (warts);
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:
. conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
condyloma acuminate, including cervical, genital, vulvar, perineal, and ● Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;
- . leukoplakia (vulvar dystrophies);
- herpes vaporization; ●
- urethral caruncle vaporization; ●
- . cervical dysplasia:
- benign and malignant tumors; ●
Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- treatment of ulcerous lesions, including aphthous ulcers; ●
- excision and ablation of benign and malignant lesions; ●
- leukoplakia;
Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:
- benign and malignant lesions of external genitalia; ●
12
- condyloma:
- erythroplasia ●
The Fractional Handpiece of the CO2RE System is indicated for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin.
The Surgical Handpiece of the CO2RE System is indicated for the following:
Dermatology & Plastic Surgery
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of:
- . vermillionectomy of the lip;
- cutaneous horns:
- removal of small skin tumors, including periungual (Koenen) and subungual fibromas; ●
- . rhinophyma reduction;
- basal and squamous cell carcinoma, including keratoacanthomas, Bowen's disease . (Erythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions:
- . neurofibromas:
Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization/coagulation of:
- benign/malignant vascular/avascular skin lesions; .
- . Moh's Surgery;
- Lipectomy; .
- Verrucae and seborrhoecae vulgares, including paronychial, periungal, and ● subunqual warts.
Laser incision and /or excision of soft tissue for the performance of upper and lower eyelid blepharoplasty.
Laser incision and /or excision of soft tissue for the creation of recipient sites for hair transplantation.
Podiatry
Laser ablation, vaporization and /or excision of soft tissue for the reduction, removal, and/or treatment of:
- . verrucae vulgares/plantar (warts), including paronychial, periungal, and subunqual warts:
Laser ablation, vaporization and /or excision in podiatry for complete or partial matrixectomy.
Otolaryngology (ENT)
Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology the treatment of:
- choanal atresia,
- nasal obstruction:
- adult and juvenile papillomatosis polyps;
- polypectomy of nose and nasal passages;
- lymphangioma removal; ●
- removal of vocal cord/fold nodules, polyps and cysts;
- . removal of recurrent papillomas in the oral cavity, nasal cavity, larynx,
pharynx and trachea, including the uvula, palatal, upper lateral pharyngeal tissue, tongue and vocal cords;
13
. laser/tumor surgery in the larynx, pharynx, nasal, ear and oral structures and tissue;
Zenker's Diverticulum/pharyngoesophageal diverticulum [endoscopic laser-● assisted esophaqodivertuculostomy (ELAED)];
-
stenosis, including subglottic stenosis;
● tonsillectomy (including tonsillar cryptolysis, neoplasma) and tonsil ablation/tonsillotomy; -
pulmonary bronchial and tracheal lesion removal;
benign and malignant nodules, tumors and fibromas (larynx, pharynx, ● trachea, tracheobronchial/endobronchial); -
benign and malignant lesions and fibromas (nose and nasal passages);
-
benign and malignant tumors and fibromas (oral);
-
stapedotomy/stapedectomy:
-
acoustic neuroma in the ear;
. superficial lesions of the ear, including chondrodermatitis nodularis chronica helices/Winkler's disease;
telangiectasia/hemangioma of larynx, pharynx and trachea (includes ● uvula, palatal or upper lateral pharyngeal tissue);
cordectomy, cordotomy (for the treatment of vocal fold paralysis/vocal ● fold motion impairment), and cordal lesions of larynx, pharynx and trachea;
- myringotomy/tympanostomy (tympanic membrane fenestration);
- uvulopalatoplasty (LAUP, laser UPPP);
- turbinectomy and turbinate reduction/ablation;
- septal spur ablation/reduction and septoplasty; ●
- partial glossectomy;
- tumor resection on oral, subfacial and neck tissues;
- rhinophyma:
- verrucae vulgares (warts); ●
- gingivoplasty/gingivoctomy.
Gynecology (GYN)
Laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of:
conization of the cervix, including cervical intraepithelial neoplasia (CIN), ● vulvar and vaginal intraepithelial neoplasia (VIN, VAIN);
condyloma acuminate, including cervical, genital, vulvar, perineal, and ● Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;
- . incision and drainage (I&D) of Bartholin's and nubuthian cysts;
- benign and malignant tumors;
- hemangiomas.
GYN Laparoscopy
Vaporization, incision, excision, ablation, or photocoagulation of soft tissue in endoscopic and laparoscopic surgery, including GYN laparoscopy, for treatment of:
- endometrial lesions, including ablation of endometriosis; ●
- excision/lysis of adhesions; ●
- salpingostomy
- oophorectomy/ovariectomy: ●
- fimbrioplasty;
- metroplasty;
14
K151655 Page 6 of 8
- microsurgery (tubal);
- uterine myomas and fibroids;
- ovarian fibromas and follicle cysts: ●
- uterosacral ligament ablation;
- hysterectomy.
Neurosurgery
Laser incision, excision, ablation and/or vaporization and of soft tissue in neurosurgery for the treatment of:
Cranial
- posterior fossa tumors;
- peripheral neurectomy; ●
- benign and malignant tumors and cysts (e.g. gliomas, menigiomas (including ● basal tumors), acoustic neuromas, lipomas and large tumors);
- arteriovenous malformation;
- pituitary gland tumors (transphenoidal approach). .
Spinal Cord
incision/excision and vaporization of benign and malignant tumors and ● cysts:
- intra- and extradural lesions;
- laminectomy/ laminotomy/ microdiscectomy. ●
Orthopedics
Incision/excision and vaporization and of soft tissue in orthopedic surgery. Applications include:
Arthroscopy .
- menisectomy;
- chondromalacia;
- . chondroplasty:
- ligament release (lateral and other);
- excision of plica; ●
- partial synovectomy.
General
- debridement of traumatic wounds; ●
- debridement of decubitus and diabetic ulcers; ●
- microsurgery;
- artificial joint revision; ●
- PMMA removal.
General/Thoracic Surgery
Incision, excision and vaporization and of soft tissue in general and thoracic surgery including endoscopic and open procedures. Applications include:
- debridement of decubitus ulcers, stasis, diabetic and other ulcers; ●
- mastectomy;
- debridement of bums;
- rectal and anal hemorrhoidectomy;
- breast biopsy;
- reduction mammoplasty;
- cytoreduction for metastatic disease;
- . laparotomy and laparoscopic applications;
15
K151655 Page 7 of 8
- mediastinal and thoracic lesions and abnormalities: ●
- skin tag vaporization;
- atheroma:
- cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips;
- pilonidal cyst removal and repair;
- abscesses;
- other soft tissue applications.
Dental/Oral Surgery
Incision/excision and vaporization of soft tissue in dentistry and oral surgery. Applications include:
- gingivectomy- removal of hyperplasias;
- . qinqivoplasty:
- incisional and excisional biopsy;
- incision of infection when used with antibiotic therapy; ●
- frenectomy (frenum release);
- excision and ablation of benign and malignant lesions: ●
- homeostasis;
- operculectomy;
- crown lengthening:
- removal of soft tissue, cysts and tumors;
- . oral cavity tumors and hemangiomas:
- abscesses:
- extraction site hemostasis;
- salivary gland pathologies;
- preprosthetic gum preparation; ●
- . partial glossectomy;
- periodontal gum resection.
Genitourinary
Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:
- benign and malignant lesions of external genitalia; ●
- condyloma; ●
- Phimosis:
- Erythroplasia.
Device Description
The Syneron CO2RE is a computer controlled radio-frequency (RF) excited carbon dioxide (CO2) laser system that delivers CO2 energy to the target treatment area at 10,600 nm. The Syneron CO>RE is comprised of multiple components, including the control unit and three handpieces (standard, fractional and surgical). Laser is transmitted to the tissue via a series of lenses integrated into the articulated arm. The CO2 laser energy is absorbed by water in tissue to achieve its intended treatment effects.
Technological Characteristics
The Syneron CO2RE technological characteristics are very similar to those of the predicate devices. The Syneron CO2RE and its predicate devices are all RF excited CO2 laser
16
systems that operate at the same or similar parameters, including wavelength, pulse duration, maximum laser power, and maximum energy. The systems are comprised of the same or similar components for the same intended use.
Performance Data
The Syneron CO2RE System performs as intended based on performance data provided in the submission.
Software: Verification and validation testing of the software confirm that the software version is appropriate for release.
Electrical Safety and Electromagnetic Compatibility: The CO2RE System has been tested for electromagnetic compatibility and electrical safety per the applicable recognized consensus standards (IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-22). Results were passing.
Biocompatibility: Biocompatibility of the patient contacting components of the device has been established per FDA's quidelines.
Sterilization: Sterilization parameters have been validated.
Performance Data: Histological analysis has been performed to evaluate the device effects across a range of treatment parameters.
Substantial Equivalence
The Syneron CO2RE System has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The technological differences between the CO2RE System and its predicate devices do not raise any new types of safety or effectiveness questions given that the key treatment parameters remain similar between the CO2RE System and its predicates. Performance testing of the CO2RE also demonstrated that the device performs as intended.
Conclusion
Syneron's CO>RE System is a CO2 laser surgical instrument for use in general and plastic surgery and in dermatology. Testing demonstrated that the device performs as intended. The CO2RE System is substantially equivalent to its predicates.