(112 days)
585nm - 600nm: The TriStar Aesthetic Workstation laser is indicated for benign vascular and vascular dependent lesions removal.
1064mm: The TriStar laser is intended for the coagulation and hemostasis of benign vascular leasions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venus laske, leg veins, spider veins and poikiloderma of civatte and treatment of benign cutaneous 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.
Additionally, the laser is indicated for the removal of unwanted hair, for the stable long tern, or permanent, hair reduction through selective targeting of melanin in hair follicles, and for the treatment of psuedofolliculitis barbae (PFB).
1320 nm: The TriStar laser is indicated for use in gental 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.
The TriStar laser is a combination of two laser devices; one pulse dye laser and the other Nd:YAG laser. They are housed in the same box with two separate laser energy delivery fibers. Laser activation is by foot switch. Overall weight of the laser is 25 Kg, and the size is 180x62x42 cm (HxWxD). Electrical requirement is 110 VAC, 15A, 50-60 Hz, single phase.
The provided text is a 510(k) summary for the TriStar Aesthetic Workstation, a medical laser system. This type of regulatory submission in the U.S. demonstrates substantial equivalence to a predicate device, rather than proving efficacy through clinical studies to meet specific acceptance criteria in the way a new drug or novel medical device might.
From the document, it explicitly states:
- Nonclinical Performance Data: none
- Clinical Performance Data: none
Therefore, a study demonstrating the device meets acceptance criteria as typically understood for new medical devices with novel claims is not present in this submission. The basis of approval is primarily substantial equivalence to predicate devices, meaning it operates on the same principle, has similar wavelengths and power ranges, and is intended for the same uses.
However, I will extract the information that is present, noting the absence of other requested details due to the nature of this 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, no specific acceptance criteria for performance metrics (e.g., specific efficacy rates for lesion removal, wrinkle reduction, or hair removal) are established or reported in tables for this 510(k) summary. The submission relies on demonstrating substantial equivalence to predicate devices (VLS-Star and PhotoGenica YAG lasers) that are already accepted as safe and effective for the stated indications.
| Acceptance Criteria (Not explicitly stated/measured in this document) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Efficacy for treatment of vascular lesions | Substantially equivalent to predicate devices (VLS-Star and PhotoGenica YAG lasers) |
| Efficacy for treatment of pigmented lesions | Substantially equivalent to predicate devices |
| Efficacy for tattoo removal | Substantially equivalent to predicate devices |
| Efficacy for wrinkle reduction | Substantially equivalent to predicate devices |
| Efficacy for hair removal (long-term, permanent, PFB) | Substantially equivalent to predicate devices |
| Safety (e.g., adverse event rates) | Substantially equivalent to predicate devices |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable. No clinical or non-clinical performance data from a test set is reported in this summary.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment for a test set is reported.
4. Adjudication method for the test set:
- Not applicable. No test set requiring adjudication is reported.
5. 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 device is a laser system, not an AI-powered diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a laser system, not an algorithm.
7. The type of ground truth used:
- Not applicable. No ground truth derived from clinical data is reported or used in this 510(k) summary beyond the implied ground truth established for the predicate devices.
8. The sample size for the training set:
- Not applicable. This device is a laser system and does not involve AI/machine learning requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.