(226 days)
The MEDIFLASH3 Intense Pulsed Light device is indicated for use in medical and aesthetic applications requiring selective photothermolysis for dermatological and medical aesthetic treatments as follows: Intense Pulsed Light Energy/Wavelengths (420nm-1200nm) - . The treatment of benign cutaneous vascular lesions including port wine stains, . hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations for Fitzpatrick Skin types I-III (Wavelengths - 515 - 1200 nm, or 500 -600 and 870 - 1200nm) - The treatment of benign pigmented epidermal and cutaneous lesions including scars and . striae for Fitzpatrick Skin types I-III (Wavelengths -550- 1200 nm) - Treatment of inflammatory acne (acne vulgaris) for Fitzpatrick Skin types I-III . (Wavelengths 420 - 1200 nm) - Removal of unwanted hair from all skin types and to effect stable long term or . permanent* hair reduction through selective targeting of melanin in hair follicles. (Light skin for Fitzpatrick Skin types I-IV Wavelengths - 620 - 1200 nm, Dark Skin for Fitzpatrick Skin types IV and V 690 – 1200 nm). MEDIFLASH3 cannot be used for skin type VI. Permanent hair reduction is defined as a long term stable reduction in the number of hairs regrowing after a treatment regime. The ESTHEFLASH3 Intense Pulsed Light device is indicated for use in medical and aesthetic applications requiring selective photothermolysis for dermatological and medical aesthetic treatments as follows: - . Removal of unwanted hair from all skin types and to effect stable long term or permanent hair reduction through selective targeting of melanin in hair follicles. (Light skin for Fitzpatrick Skin types I-IV Wavelengths - 620 - 1200 nm, Dark Skin for Fitzpatrick Skin types IV and V 690 - 1200 nm). ESTHEFLASH 3 cannot be used for skin type VI. *Permanent hair reduction is defined as a long term stable reduction in the number of hairs regrowing after a treatment regime.
The MEDIFLASH3 and ESTHEFLASH3 Intense Pulsed Light Device Systems are light based medical devices that deliver a flash of pulsed non-ionizing radiation within the spectral range covering 400 to 1200 nanometers. The system is designed to be compact and self contained and includes the following features: - t Control console unit - Display panel . - Power supply . - . Cooling system - Hand piece with detachable cartridge with lamp, mirror and filter .
Here's a breakdown of the acceptance criteria and the study information for the MEDIFLASH3 and ESTHEFLASH3 Intense Pulsed Light Systems, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance (Based on available information):
The 510(k) summary does not explicitly define specific performance acceptance criteria in terms of numerical thresholds for clinical efficacy (e.g., % hair reduction, % lesion clearance). Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (McCue Energist Ultra Variable Pulsed Light K060234) in terms of intended use, design, mode of operation, and performance characteristics.
The "device performance" reported is primarily that the system is capable of providing the outputs necessary to achieve its required treatment parameters and that it introduces no new questions concerning safety or effectiveness.
| Acceptance Criteria Category | Reported Device Performance (as implied or stated) |
|---|---|
| Electrical Safety | Device performed to UL 60101-1 standards, indicating compliance with electrical safety requirements. |
| Electromagnetic Compatibility (EMC) | Device performed to FCC 60601-1-2 standards, indicating compliance with EMC requirements. |
| Output Capability | System is capable of providing the outputs necessary to achieve its required treatment parameters (e.g., specific wavelengths, energy delivery). |
| Substantial Equivalence | Device is substantially equivalent to the predicate device (McCue Energist Ultra) in intended use, design, mode of operation, and performance characteristics. |
| Safety and Effectiveness | Device introduces no new questions concerning the safety or effectiveness compared to the predicate device. |
Study Information:
-
Sample size used for the test set and the data provenance:
- The document does not mention any specific clinical test set data from human subjects for performance or efficacy. The tests reported are limited to electrical safety and EMC.
- Data Provenance: Not applicable as there are no reported clinical test sets.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical test set data from human subjects is reported.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set data from human subjects is reported.
-
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:
- No, an MRMC comparative effectiveness study was not done. This device is an IPL system, not an AI-assisted diagnostic or imaging device.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not a standalone algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the reported engineering tests (electrical safety, EMC), the "ground truth" would be compliance with the specific standards (UL 60101-1, FCC 60601-1-2) as measured by laboratory equipment and procedures.
- No clinical ground truth (e.g., pathology, outcomes data) for efficacy is reported in this summary. The substantial equivalence argument relies on the predicate device's established safety and effectiveness.
-
The sample size for the training set:
- Not applicable. This document describes a physical medical device submission, not a machine learning model, so there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for a machine learning model.
§ 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.