(36 days)
The SmartCool family cold air device is intended to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief.
The SmartCool family cold air device consists of a refrigeration unit that creates cold air. The cold air is blown onto the skin using an air hose.
The provided K090618 document for the Cynosure SmartCool family cold air device does not contain information about acceptance criteria or a study proving it meets those criteria.
This 510(k) summary explicitly states:
- Nonclinical Performance Data: none
- Clinical Performance Data: none
Instead, the submission relies on demonstrating substantial equivalence to predicate devices (Cryo 5 (K040727), Cryo V6 (K060395), and CryoMini (K080735)) by having the "same indications for use, the same principle of operation, and the same performance."
Therefore, I cannot provide the requested table and details because the submission indicates that no specific performance study was conducted to establish acceptance criteria for this 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.