(77 days)
Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers (and the delivery accessories that are used with them to deliver laser energy) are indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), arthroscopy (knee), and open and endoscopic general surgery.
Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers are indicated for use in the performance of specific surgical applications in dermatology, plastic surgery, podiatry, neurosurgery, gynecology, otorhinolaryngology (ENT), and open and endoscopic general surgery as follows:
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 derm-abrasion
- Laser burn debridement.
- Laser skin resurfacing (ablation and/or vaporization) in dermatology and plastic surgery for the treatment of wrinkles, rhytids and furrows.
Clinical study demonstrated that skin resurfacing of wrinkles, rhytids, and furrows with the ULTRAPULSE CO2 surgical laser increases the amount of sub-epidermal collagen. - Laser skin resurfacing (ablation and/or vaporization) of soft tissue in dermatology and plastic surgery for the reduction, removal, and / or treatment of:
- actinic keratosis
- solar / actinic elastosis
- actinic cheilitis
- lentigines
- uneven pigmentation/dyschromia
- acne scars
- surgical scars
- keloids
- hemangiomas (including buccal hemangiomas)
- tattoos
- telangiectasia
- squamous cell carcinoma
- epidermal nevi
- xanthelasma palpebrarum
- syringoma
- verrucae vulgares (warts).
Dermatology, Plastic Surgery & General Surgery
- Laser incision and/or excision of soft tissue in dermatology, plastic and general surgery for the performance of blepharoplasty.
- Laser incision and/or excision of soft tissue in dermatologf, plastic and general surgery for the creation of recipient sites for hair transplantation.
Podiatry
- Laser ablation, vaporization, and/or excision of soft tissue in podiatry for the reduction, removal, and/or treatment of:
- verrucae vulgares (warts)
- Laser ablation, vaporization, and/or excision in podiatry for matrixectomy.
Otorhinolaryngology (ENT)
- Laser incision, excision, ablation and/or vaporization of soft tissue in otorhinolaryngology for the treatment of:
- choanal atresia
- leukoplakia of larynx
- nasal obstruction
- adult and juvenile papillomatosis polyps
- rhinophyma
- verrucae vulgares (warts)
Gynecology
- Laser incision, excision, ablation and/or vaporization of soft tissue in gynecology for the treatment of:
- cervical intraepithelial neoplasia
- condyloma acuminata
- leukoplakia (vulvar dystrophies)
- vulvar and vaginal intraepithelial neoplasia
Neurosurgery
- Laser incision, excision, ablation and/or vaporization of soft tissue ja neurosurgery for the treatment of:
- basal tumor-meningioma
- posterior fossa tumors
- peripheral neurectomy
- lipomas/large tumors
The Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers (and their delivery accessories) are intended to be used to deliver carbon dioxide light energy for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in a variety of medical specialties.
Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers are comprised of the following main components:
- a laser console
- a console articulated arm mount
- a counterbalanced articulated arm
- control and display panels
- system microprocessor control electronics and operating software
- a covered footswitch or handswitch for specific delivery device accessories
- a filtered air pump purge system with an insufflator filter for purge of delivery device accessories
- a variety of delivery device accessories or handpieces.
I am sorry, but based on the provided text, there is no information about "acceptance criteria" and "device performance" in the context of a scientific study or clinical trial with specific metrics like sensitivity, specificity, accuracy, or any statistical analysis.
The document is a 510(k) summary statement for the Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving performance against specific acceptance criteria through a newly conducted study as one would expect for a novel device.
Here's what the document does provide:
- Device Description and Indications for Use: It describes the device and lists the surgical applications and medical specialties for which it is intended.
- Predicate Devices: It identifies previously cleared devices to which the new device is compared for demonstrating substantial equivalence.
- Rationale for Substantial Equivalence: It states that the new device shares "the same indications for use, similar design features, and functional features" with the predicate devices.
- Safety and Effectiveness Information: It generally states that "Safety and effectiveness information was provided to demonstrate that the Coherent ULTRAPULSE S Series Carbon Dioxide Surgical Lasers are safe and effective, when indicated for use..." However, it does not detail what that information entailed (e.g., specific study results, performance metrics).
- Conclusion: It concludes that the device was found to be "substantially equivalent" to currently marketed and predicate surgical laser devices.
Therefore, I cannot fill in the requested table or provide the details about sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies because this information is not present in the provided 510(k) summary. The document is a regulatory filing focused on substantial equivalence rather than a performance study report.
§ 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.