(89 days)
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 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 .
- 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.
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.
The provided document is a 510(k) Premarket Notification from the FDA for the Syneron CO2RE Laser System. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a study with performance metrics in the typical sense of a diagnostic or AI-driven device.
Therefore, many of the requested elements (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable or cannot be extracted from this type of regulatory submission. This document describes the device's intended uses, technological characteristics, and results of various safety and performance tests, but not a study of its clinical diagnostic performance against specific acceptance criteria with quantifiable metrics.
Here's an attempt to answer the questions based only on the information available in the provided text:
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria with corresponding performance metrics in a quantifiable sense (e.g., sensitivity, specificity, accuracy) as would be expected for a diagnostic or AI device. Instead, it states that the device "performs as intended" based on various tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Software Verification & Validation | Software version is appropriate for release. |
| Electrical Safety & Electromagnetic Compatibility | Passed applicable recognized consensus standards (IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-22). |
| Biocompatibility | Biocompatibility of patient-contacting components established per FDA guidelines. |
| Sterilization | Sterilization parameters validated. |
| Performance Data | Histological analysis performed to evaluate device effects across a range of treatment parameters. Device performs as intended. |
| Substantial Equivalence | Has the same intended use and similar indications, technological characteristics, and principles of operation as predicate devices. Technological differences do not raise new safety/effectiveness questions, and performance testing showed the device performs as intended. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "histological analysis" but does not specify the sample size, data provenance, or whether it was a test set in the context of a statistical study to meet performance criteria.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document describes a laser system intended for surgical and dermatological applications, not a diagnostic device requiring expert interpretation for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document and is not applicable to the type of device and testing described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not provided in the document and is not applicable. The device is a surgical laser system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document and is not applicable. The device is a physical laser system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the performance data, the document mentions "Histological analysis has been performed to evaluate the device effects across a range of treatment parameters." Histological analysis generally refers to the examination of tissue samples under a microscope, which would serve as a form of pathological ground truth for evaluating the effects of the laser on tissue. No other type of ground truth is explicitly mentioned for clinical effectiveness.
8. The sample size for the training set
This information is not provided in the document. The device is a physical laser system, not an AI algorithm that typically requires a training set.
9. How the ground truth for the training set was established
This information is not provided in the document, as it's not relevant for this type of device.
§ 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.