(70 days)
The indications for use for the RL-S20S-TWC include:
The Super Hair Removal (SHR) Mode are intended for temporary hair reduction.
The indications for use for the RL-S20S-755A include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick L-VI), including tanned skin.(HR. SHR Modes)
The indications for use for the RL-S20S-810B include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term. stable reduction in the number of airs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, and SHR Modes)
Not Found
The provided FDA 510(k) clearance letter and Indications for Use document for the Artemis Diode Laser System do not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.
The document primarily focuses on:
- Confirming the substantial equivalence of the device to legally marketed predicates.
- Listing the specific Indications for Use, which primarily involve temporary or permanent hair reduction across different skin types.
- Outlining regulatory compliance requirements (e.g., Quality System regulation, adverse event reporting).
Therefore, based solely on the provided text, it is not possible to answer your questions about the acceptance criteria, device performance study details, or ground truth establishment. This information would typically be found in the full 510(k) submission, which is not included here.
§ 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.