(57 days)
1064nm: The Cynosure Affirm 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, venus lake, leg veins, spider veins and poikiloderma of civatte; and treatment of benign cutaneous lesions such as warts, 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 (significant reduction in the intensity 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.
1320nm: The Cynosure Affirm 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 periorbital and perioral wrinkles. It is also indicated for the treatment of fine lines and wrinkles.
1440nm: The Cynosure Affirm 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 periorbital and perioral wrinkles and pigmented lesions.
The XPL Pulsed Light System Handpiece is intended for permanent hair reduction and the treatment of dermatological vascular lesions, facial and leg veins, benign pigmented lesions, and inflammatory acne.
The Affirm Family System Laser Attachment is intended for: Er:YAG 2,940 nm - for skin resurfacing and for the incision, excision, ablation or vaporization of soft bodily tissues.
The Affirm Family Laser with XPL Handpiece and Er:YAG Laser Module is a Nd:YAG laser system. It emits wavelengths at 1064nm, 1320nm, and 1440nm. It also incorporates an XPL Handpiece an a Er:YAG Module.
Laser emission activation is by foot switch. Overall weight of the laser is 180 lbs., and the size is 65" x 23" x 68" (LxWxH).
Electrical requirement is 230 VAC, 15A, 50-60 Hz, single phase.
This 510(k) summary (K080006) for the Cynosure Affirm Family Laser with XPL Handpiece and Er:YAG Laser Module does not provide a typical set of acceptance criteria based on quantifiable performance metrics or a detailed clinical study proving device meets such criteria.
Instead, the submission relies on the concept of substantial equivalence to predicate devices. This means that to be cleared, the device demonstrates that it is as safe and effective as a legally marketed device (the predicate) that was on the market before May 28, 1976, or has been reclassified.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary relying on substantial equivalence for a laser system, traditional "acceptance criteria" for performance in the sense of accuracy, sensitivity, or specificity (as one might see for diagnostic devices or AI algorithms) are not presented. Instead, the "acceptance criteria" are implicitly met by demonstrating that the new device has:
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as stated in 510(k) Summary) |
|---|---|
| Same Indications for Use | The Cynosure Affirm Family Laser has the "same indications for use" as the predicate devices. |
| Same Principle of Operation | The Cynosure Affirm Family Laser has the "same principle of operation" as the predicate devices. |
| Same Wavelengths | The Cynosure Affirm Family Laser has the "same wavelength" as the predicate devices. |
| Safe and Effective for Specified Indications | "The Cynosure Affirm Family Laser is a safe and effective device for the indications specified." (This is a conclusion, not a performance metric). |
Note: The 510(k) summary explicitly states "Nonclinical Performance Data: none" and "Clinical Performance Data: none." This indicates that no new, specific performance studies were conducted to define and meet new, explicit acceptance criteria beyond demonstrating equivalence to existing devices.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No separate "test set" or clinical study with a defined sample size for performance evaluation is mentioned. The submission relies on the established safety and efficacy of the predicate devices.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. Ground truth establishment by experts for a test set is not part of this type of substantial equivalence submission.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. An MRMC comparative effectiveness study was not done, as there is no mention of human readers or AI assistance in the context of this laser system. The device is a therapeutic laser, not an AI-assisted diagnostic or interpretation tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is a physical laser device, not an algorithm. Therefore, a standalone algorithm performance study is not relevant or applicable.
7. Type of Ground Truth Used
Not applicable. The clearance is based on substantial equivalence to predicate devices, whose "ground truth" (i.e., their demonstrated safety and effectiveness for their intended uses) was established through previous regulatory clearances or historical usage.
8. Sample Size for the Training Set
Not applicable. This device is a laser system and does not involve AI or machine learning that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth to be established for it.
§ 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.