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 CO-RE 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 lines 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 sebortheic keratosis, sebortheic wart, and verruca sebortheica;
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 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;
syringoma

Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization 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, 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);

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, vulvar, perineal, and Bowen's disease, (Erythroplasia of Quevrat) 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 subungual warts.

Laser incision and /or excision of soft tissue for the performance of upper and lower evelid 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 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 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, 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 (larynx, 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 and trachea (includes uvula, palatal or upper lateral pharyngeal tissue);
cordectomy, cordotomy (for the treatment of 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; 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, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;
incision and drainage (1&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 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 (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;
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 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 CO₂RE System 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 CO2RE Laser System is comprised of multiple components, including the control unit and six handpieces. 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.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) summary relating to the CO2RE Laser System, focusing on the requested acceptance criteria and study details.

Important Disclaimer: The provided document is a 510(k) Summary, not a full 510(k) submission. A 510(k) Summary focuses on demonstrating substantial equivalence to a predicate device, and often relies on existing knowledge of the technology rather than extensive novel clinical studies. Therefore, many of the requested details about acceptance criteria, human reader studies, and detailed ground truth establishment might not be explicitly present or required for a 510(k) submission for this type of device. The information provided below is extracted directly from the given text.

Acceptance Criteria and Device Performance for CO2RE Laser System (K181523)

1. Table of Acceptance Criteria and Reported Device Performance

Criterion / Aspect	Acceptance Criteria (Implicit for 510(k) based on predicate)	Reported Device Performance (Summary of Study Findings)
Intended Use	Same as predicate device (CO₂RE Laser System K151655) for surgical applications requiring ablation, vaporization, excision, incision, and coagulation of soft tissue.	"The CO₂RE System has the same intended use... as its predicate devices."
Technological Characteristics	Similar to predicate device (CO₂RE Laser System K151655) including wavelength, pulse duration, maximum laser power, and maximum energy.	"The CO₂RE System technological characteristics are very similar to those of the predicate devices. The CO₂RE System and its predicate devices are all RF excited CO₂ laser systems that operate at the same or similar parameters... The systems are comprised of the same or similar components for the same intended use."
Performance (General)	Performs as intended for a CO2 laser surgical instrument.	"The CO₂RE System performs as intended based on the performance data provided in the submission."
Software Verification & Validation	Software is appropriate for release.	"Verification and validation testing of the software confirm that the software version is appropriate for release."
Electrical Safety & Electromagnetic Compatibility (EMC)	Meets applicable recognized consensus standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22).	"The CO₂RE System has been tested for electromagnetic compatibility and electrical safety per the applicable recognized consensus standards... Results were passing."
Biocompatibility	Established per FDA's guidelines for patient-contacting components.	"Biocompatibility of the patient contacting components of the device has been established per FDA's guidelines."
Sterilization	Sterilization parameters are validated.	"Sterilization parameters have been validated."
Safety and Effectiveness Questions	Technological differences do not raise new safety or effectiveness questions compared to predicate.	"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..."
Overall Conclusion	Substantially equivalent to predicate.	"The CO₂RE System is substantially equivalent to its predicate."

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

The document does not describe a "test set" in the context of typical AI/software performance validation involving patient data. For this laser device, the "testing" refers to engineering and quality assurance tests on the device itself.

Sample Size: Not applicable in the traditional sense of a clinical test set for diagnostic accuracy. Testing was conducted on the device's components and system.
Data Provenance: Not applicable. The "data" here refers to measurements from electrical safety, EMC, software, biocompatibility, and sterilization tests. These are internal lab tests, not patient data.

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

Number of Experts: Not applicable. Ground truth, in the context of a medical laser device for surgical and dermatological procedures, typically relies on established medical knowledge, clinical outcomes, and the device's physical/electrical parameters meeting specified standards. It doesn't involve "experts" labeling a test set of images or patient data for an algorithm.
Qualifications of Experts: Not applicable for the type of testing described.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The device's performance is demonstrated through adherence to engineering standards and technical specifications, not through a diagnostic assessment requiring expert adjudication of results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

MRMC Study: No. This is a laser surgical instrument, not an AI-assisted diagnostic tool where human readers compare performance with and without AI. The submission focuses on demonstrating the device's technical specifications and safety/effectiveness equivalence to a predicate, not improving human reader performance.
Effect Size: Not applicable.

6. If a Standalone (Algorithm Only Without Human-in-the-loop Performance) Was Done

Standalone Performance: Not applicable. This device is a directly operated laser system, not an artificial intelligence algorithm that operates independently or provides diagnostic output. It does not have an "algorithm only" mode in the sense of AI performance evaluation. The "software" mentioned refers to the operating software of the physical device.

7. The Type of Ground Truth Used

Type of Ground Truth: For this type of device, "ground truth" is established by:
- Engineering Specifications and Benchmarks: The device's output (e.g., laser power, wavelength, pulse duration) must meet design specifications.
- Industry Consensus Standards: Compliance with recognized standards like IEC 60601-1 for electrical safety and electromagnetic compatibility.
- Predicate Device Performance: The primary ground truth for a 510(k) is the demonstration of substantial equivalence to a legally marketed predicate device, implying that if the predicate is safe and effective, the new device with similar characteristics and performance also is.
- Biocompatibility Data: Established guidelines for material safety.
- Sterilization Validation: Demonstrated ability to be safely sterilized.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device does not use machine learning with a "training set" of data in the typical sense. Its functionality is based on established physical principles of laser operation.

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

Ground Truth for Training Set Establishment: Not applicable, as there is no "training set" for an AI algorithm.

Summary of 510(k) Specifics for CO2RE Laser System:

This 510(k) submission for the CO2RE Laser System (K181523) is an example of a substantial equivalence determination for a medical device that is not an AI/ML-driven diagnostic or therapeutic tool. Its 'acceptance criteria' and 'study' are primarily centered around:

Predicate Equivalence: Demonstrating that the new device has the same intended use and similar technological characteristics, indications, and principles of operation as a previously cleared device (K151655).
Performance Testing: Laboratory and engineering tests to ensure the device meets declared technical specifications, electrical safety, EMC, biocompatibility, and sterilization requirements.
Software Validation: Ensuring the embedded software controls the device appropriately and safely.

The framework for evaluating AI/ML devices with detailed criteria like MRMC studies, expert adjudication, and distinct training/test sets is not applicable to a device like the CO2RE Laser System.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

July 11. 2018

Syneron-Candela Corp Sharon Timberlake VP. Global Regulatory and Clinical Affairs 530 Boston Post Road Wayland, Massachusetts 01778

Re: K181523

Trade/Device Name: 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 8, 2018 Received: June 11, 2018

Dear Sharon Timberlake:

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Binita S. Ashar -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181523

Device Name CO2RE Laser System

Indications for Use (Describe)

The CO-RE 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 lines 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 sebortheic keratosis, sebortheic wart, and verruca sebortheica; · 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 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;

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· 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;
syringoma

Laser ablation, vaporization and /or excision for complete or partial nail matrixectomy. Vaporization 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, 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);

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, vulvar, perineal, and Bowen's disease, (Erythroplasia of Quevrat) 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:

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· 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 subungual warts.

Laser incision and /or excision of soft tissue for the performance of upper and lower evelid 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 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 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, 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 (larynx, 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 and trachea (includes uvula, palatal or upper lateral pharyngeal tissue);

· cordectomy, cordotomy (for the treatment of vocal fold motion impairment), and cordal lesions of larynx, pharynx and trachea;

· myringotomy/tympanostomy (tympanic membrane fenestration);

· uvulopalatoplasty (LAUP, laser UPPP);

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· turbinectomy and turbinate reduction; 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, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions;

· incision and drainage (1&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 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 (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.

{6}------------------------------------------------

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 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.

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Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary CO2RE System

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92

1. DATE PREPARED June 8, 2018

2. APPLICANT NAME

Candela Corporation 530 Boston Post Road Wayland, MA 01778 P: (508) 358-0304

M: (617) 957-1434

3. Official Correspondent

Sharon Timberlake, MSHS, RAC, CCRA VP, Global Clinical & Regulatory Affairs Candela Corporation 530 Boston Post Road Wayland, MA 01778 P: (508) 358-0304 M: (617) 957-1434 sharont@syneron-candela.com

4. Device Information

Proprietary Name:	CO2RE Laser System
Common/Usual Name:	CO2 Laser
Classification Name:	Laser surgical instrument for use in General and Plasticsurgery and in dermatology (21 CFR Section 878.4810)
Product Code:	GEX
Device Classification:	Class 2
Laser Classification:	Class IV

5. Predicate Device

Syneron CO2RE Laser System (K151655)

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6. INDICATIONS FOR USE

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
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;

{10}------------------------------------------------

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;
syringoma

Laser ablation, vaporization and /or 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;

{11}------------------------------------------------

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);

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:

{12}------------------------------------------------

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 ● subungual 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 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;
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:

{13}------------------------------------------------

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 (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;

{14}------------------------------------------------

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.

{15}------------------------------------------------

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 gum preparation;
partial glossectomy; ●
periodontal gum resection.

Genitourinary

Incision/excision and vaporization and of soft tissue in genitourinary procedures. Applications include:

{16}------------------------------------------------

benign and malignant lesions of external genitalia;
condyloma; ●
Phimosis;
Erythroplasia. ●

7. DEVICE DESCRIPTION

8. TECHNOLOGICAL CHARACTERISTICS

The CO2RE System technological characteristics are very similar to those of the predicate devices. The CO2RE System and its predicate devices are all RF excited CO2 laser 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.

9. PERFORMANCE DATA

The CO2RE System performs as intended based on the 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 guidelines.

Sterilization: Sterilization parameters have been validated.

10. SUBSTANTIAL EQUIVALENCE

The 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

{17}------------------------------------------------

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 System also demonstrated that the device performs as intended.

11. Conclusion

The CO2RE 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 predicate.

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.