(55 days)
1064nm: The Cynosure YAG MIR Family laser is intended for the coagulation and hemostasis of benign vascular lesions, such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, scars, striae and poikiloderma of civatte; and treatment of telangiectasia, rosacea, venous lakes, scars, striae and psoriasis. The laser is also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), Café au lait macules, seborrheic keratoses, nevi, chloasma, verrucea, skin tags, keratoses, tattoos (for removal of black and/or blue/black tattoos) and plaques.
The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
Additionally, the laser is indicated for the removal of unwanted hair, for the stable long term, or permanent reduction of hair, for the treatment of melanin in the hair follicles, and for the treatment of pseudofolliculitis barbae (PFB).
1440mm: The Cynosure YAG MIR Family laser is indicated for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue. It is also indicated for the treatment of periocular and perioral wrinkles and pigmented lesions.
The Cynosure YAG MIR Family laser is a Nd:YAG laser, having a ND:YAG crystal rod as a lasing medium. Laser activation is by footswitch or finger switch. Overall weight of the laser is 285lbs, and the size is 41"x18"x32" (HxWxD). Electrical requirement is 220 VAC, 30A, 50-60 Hz, single phase.
This submission is for a medical laser system, a device that typically does not involve algorithms or AI. Therefore, most of the questions regarding acceptance criteria, study details, and AI performance metrics are not applicable.
Here's the information extracted from the provided text, primarily based on the 510(k) summary (section {0}) and the FDA letter {1-3}.
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the submitted 510(k) summary. For medical devices like lasers, acceptance criteria would typically involve performance specifications for energy output, wavelength, pulse duration, spot size, safety features, and possibly clinical efficacy endpoints. Since the submission states "Nonclinical Performance Data: none" and "Clinical Performance Data: none", there are no reported device performance metrics against specific acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No test set was used as no clinical or non-clinical performance data was submitted.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No test set and no ground truth establishment were mentioned for this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. No test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
Not applicable. No clinical studies, including MRMC studies, were reported or performed for this 510(k) clearance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a laser system and does not involve an algorithm or AI component.
7. The Type of Ground Truth Used
Not applicable. No ground truth was established as no performance data was provided.
8. The Sample Size for the Training Set
Not applicable. This device is a laser system and does not involve an AI model with a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This device is a laser system and does not involve an AI model requiring a training set or its associated ground truth.
Summary of the 510(k) Submission:
The Cynosure YAG MIR Family Laser is a predicate device clearance. The FDA's decision to clear the device is based on its substantial equivalence to already legally marketed predicate devices. This means that the FDA determined the device has the same intended use, same principle of operation, and similar technological characteristics (wavelengths, pulse energy range) to devices already on the market.
Crucially, for this specific 510(k) submission, no new clinical or non-clinical performance data was required or submitted to demonstrate safety and effectiveness. The substantial equivalence argument relies on the established safety and effectiveness of the predicate device(s). Therefore, the detailed questions about acceptance criteria, performance studies, and ground truth establishment, which are common for submissions involving novel technologies or performance claims, are not applicable in this case.
§ 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.