(60 days)
The PhotoMedex LaserPro CO2 Carbon Dioxide Laser System, when used with the delivery accessories identified in the Users Instructions (used to deliver laser energy), is indicated for use in surgical applications requiring the ablation, vaporization, excision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery.
The LaserPro CO2 Surgical Laser is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology (including laparoscopy), neurosurgery, orthopedics (soft tissue), arthroscopy (knee), general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery as follows:
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 derm-abrasion; Laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) for treatment of: wrinkles, rhytids, and furrows (including fine lines and texture irregularities). 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 homs; solar/actinic clastosis; cheilitis, including actinic cheilitis; 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 fibmromas; 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 (Frythroplasia of Queyrat), and Bowenoid Papulosis (BP) lesions; nevi, including spider, epidermal and protruding; neurofibromas; laser de-epithelialization; tricoepitheliomas; xanthelasma palpebrarurn; syringoma. Laser ablation, vaporization and/or excision for complete and partial nail matrixectomy. Vaporization/coagulation of: Benign/malignant vascular/avascular skin lesions; Moh's Surgery; lipectomy; verrucae and seborthoecae 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; fungal nail treatment; porokeratoma ablation; ingrown nail treatment; neuromas/fibromas, including Morton's neuroma; debridement of ulcers; other soft tissue lesions.
Genitourinary: Incision, excision and vaporization of soft tissue in genitourinary procedures. Applications include: benign and malignant lesions of external genitalia; condyloma; phimosis; erythroplasia.
Otolaryngology (ENT): Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for treatment of: choana1 atresia; leukoplakia, including oral, larynx, uvula, palatal, upper lateral pharyngeal tissue; 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 esophagodiverticulostomy (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/endobronchia1); 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 car, incl. chondrodermatitis nondularis 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/gingivectomy.
Gynecology (GYN): Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology (GYN) for treatment of: conization of the cervix, including cervical intraepithelial neoplasia (CIN), vulvar and vaginal intraepithelial neoplasia VIN. VAIN); condyloma acuminata, including cervical, genital, vulvar, perineal, and Bowen's disease, (Erythroplasia of Queyrat) and Bowenoid papulosa (BP) lesions; leukoplakia (vulvar dystrophies); incision and drainage (I&D) of Bartholin's and nubuthian cysts; herpes vaporization; urethral caruncle vaporization; cervical dysplasia; 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; fimbroplasty; metroplasty; microsurgery (tubal); uterine myomas and fibroids; ovarian fibromas and follicle cysts; uterosacral ligament ablation; hysterectomy.
Neurosurgery: Laser incision, excision, ablation and/or vaporization of soft tissue in neurosurgery for the treatment of: Cranial: Posterior fossa tumors; peripheral neurectomy; arteriovenous malformation; benign and malignant tumors and cysts [e.g. gliomas, menigiomas (including basal tumors), acoustic neuromas, lipomas and large tumors]; pituitary gland tumors (transsphenoidal approach). Spinal Cord: incision/excision and vaporization of benign and malignant tumors and cysts; Intra- and extradural lesions; laminectomy/ laminotomy/ microdiscectomy.
General and Thoracic Surgery: Incision, excision and vaporization 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 burns; rectal and anal hemorrhoidectomy; breast biopsy; reduction mammoplasty; cytoreduction for metastatic disease; laparotomy and laparoscopic applications; skin tag vaporization; atheroma; abscesses; other soft tissue applications; mediastinal and thoracic lesions and abnormalities; cysts, including sebaceous cysts, pilar cysts, and mucous cysts of the lips; pilonidal cyst removal and repair.
Orthopedics: Incision, excision and vaporization of soft tissue in orthopedic surgery. Applications include: Arthroscopy: menisectomy; chondromalacia; chondroplasty; excision of plica; partial synovectomy; ligament release (lateral and other). General: debridement of traumatic wounds; debridement of decubitus and diabetic ulcers; microsurgery; artificial joint revision; PMMA removal.
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; frenectomy (frenum release); treatment of ulcerous lesions, including aphthous ulcers; incision of infection when used with antibiotic therapy; excision and ablation of benign and malignant lesions; homcostasis; 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; leukoplakia; partial glossectomy; periodontal gum resection.
The PhotoMedex LaserPro CO2 carbon dioxide laser system is designed to provide infrared laser power at a wavelength of 10,600nm which can be used for the procedures indicated in the next section. The system is comprised of the following main components: A laser console, A laser console tower, Display panel with soft-touch keypad control and separate Emergency Off button, Laser system microprocessor control electronics with operating software, A seven segment counterbalanced articulated arm designed to accept the delivery accessories defined in CHART A located in the next section, A detachable covered footswitch.
The provided text is a 510(k) summary for the PhotoMedex LaserPro CO2 Carbon Dioxide Laser System. This document is a premarket notification for a medical device and, as such, focuses on demonstrating substantial equivalence to predicate devices rather than proving new efficacy or safety through novel studies with specific acceptance criteria that would typically be found in an AI/ML device submission.
Therefore, many of the requested items related to acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes, ground truth establishment, and expert qualifications are not applicable to this type of submission. This 510(k) primarily relies on adherence to recognized standards and similarity to previously cleared devices.
Here's an assessment based on the available information:
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A table of acceptance criteria and the reported device performance
- Not Applicable. This submission is for a laser surgical instrument, a hardware device, seeking clearance based on substantial equivalence to existing predicate devices. It does not present specific performance metrics or acceptance criteria in the way an AI/ML device would (e.g., sensitivity, specificity, AUC). Instead, it states compliance with general safety and performance standards.
- The "performance" is implicitly demonstrated through adherence to the following standards:
- 21 CFR 1040.10 & 1040.11 (Performance Standards for Laser Products)
- PART 820 – Quality System Regulation
- EN60601-1 (Medical electrical equipment – Part 1: General requirements for basic safety and essential performance)
- EN60601-1-2 (Electromagnetic compatibility – Requirements and tests)
- EN60601-2-22 (Particular requirements for basic safety and essential performance of surgical, therapeutic and diagnostic laser equipment)
- EN 60601-1-4 (General requirements for safety – Collateral Standard: Programmable electrical medical systems)
- EN ISO 14971 (Medical devices – Application of risk management to medical devices)
- IEC60825 (Safety of laser products)
- UL2601-1 / UL60601-1 (Medical Electrical Equipment – Part 1: General Requirements for Safety)
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No explicit test set or clinical data (in the sense of a data-driven AI/ML study) is described. The device's safety and effectiveness are established through compliance with recognized standards and comparison to predicate devices, not through a clinical performance study with a test set of patient data.
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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)
- Not Applicable. As no specific data-driven test set is described, there's no mention of experts establishing ground truth for such a set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No test set or related adjudication method is mentioned.
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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
- Not Applicable. This is a hardware laser device, not an AI/ML diagnostic or assistive device. Therefore, no MRMC study would be applicable or expected.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware laser device, not an algorithm.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. Ground truth in the context of AI/ML performance assessment is not relevant for this device. The "ground truth" for this submission is adherence to engineering and safety standards, and the established safety and efficacy of the predicate devices for similar indications.
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The sample size for the training set
- Not Applicable. This is a hardware device. AI/ML training sets are not relevant here.
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How the ground truth for the training set was established
- Not Applicable. As no training set or AI/ML component is involved, ground truth establishment for a training set is irrelevant.
Summary of the Study Proving Device Meets Acceptance Criteria (as described in the 510(k)):
The study proving the device meets the "acceptance criteria" (which are more accurately described as regulatory and engineering standards, and substantial equivalence requirements) is detailed in Section 7, "SAFETY AND EFECTIVENESS; PRODUCT PERFORMANCE."
- Study Design: The submission indicates that the PhotoMedex LaserPro CO2 Carbon Dioxide Laser System is "designed, tested and will be manufactured in accordance with both mandatory and voluntary standards." This indicates a verification and validation process against recognized standards rather than a clinical trial with performance metrics against a clinical ground truth.
- Proof of Safety and Effectiveness: The primary "proof" for this 510(k) submission lies in demonstrating:
- Compliance with Standards: The device meets several mandatory and voluntary standards related to medical electrical equipment and laser products (listed in point 1 above).
- Substantial Equivalence: The device is substantially equivalent to legally marketed predicate devices (Lumenis Modified Family of UltraPulse SurgiTouch CO2 Laser Systems (K030147) and Lumenis UltraPulse Encore Carbon Dioxide Laser and Delivery Device Accessories (K022060)) in terms of intended use, technological characteristics, and performance. The argument for substantial equivalence is based on the new device having similar design, same indications for use, and similar fundamental scientific technology as the predicates, and that "[n]o new clinical indications are to be provided" by the new device.
- Methodology: The submission states that a "review of the predicate devices... demonstrates that the LaserPro CO2 Carbon Dioxide Laser System... is safe and effective as the predicate devices in conjunction with the specified wavelengths, and are used to perform the same indicated surgical procedures." This "review" would involve comparing the technical specifications, performance data (such as wavelength, power output, safety features), and indications for use of the new device to the cleared predicate devices.
In essence, for this type of medical device (a laser surgical instrument), the "study" is a comprehensive engineering and regulatory assessment demonstrating that the device adheres to established safety profiles, meets relevant performance standards, and is equivalent to other devices already legally on the market for the proposed indications.
§ 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.