(108 days)
The StarWalker Laser System Family is indicated for:
1064 nm wavelength in Q-switched mode:
-Removal of dark (black, blue, brown) tattoo ink
-Treatment of nevus of ota
-Treatment of common nevi
-Removal and lightening of unwanted hair
-Skin resurfacing procedures for the treatment of acne scars and wrinkles
-Treatment of melasma
-General dermatology indications: Incision, excision, ablation and vaporization of soft tissue
1064 nm wavelength in long pulse mode:
-Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The laser is indicated for all skin types, Fitzpatrick I-VI, including tanned skin
-Photocoagulation and hemostasis of benign pigmented and benign vascular lesions, such as, but not limited to,
port wine stains, hemaongiomae, warts, telangiectasiae, rosacea, venus lake, leg veins and spider veins
-Coagulation and hemostasis of soft tissue
-Treatment of wrinkles
-Treatment of mild to moderate inflammatory acne vulgaris
1064 nm wavelength in PICO mode:
-Removal of tattoos for all skin types (Fitzpatrick I-VI) to treat the following tattoo colors: black, brown, green, blue and purple
-Benign pigmented lesions removal for Fitzpatrick Skin Types I-IV
-Treatment of acne scars in Fitzpatrick Skin Types II-V
-Treatment of wrinkles as well as benign pigmented lesions in Fitzpatrick Skin Types I-IV
532 nm wavelength in Q-switched mode (nominal delivered energy of 585 mm with the optional 585 nm and 650 nm dye converter handpieces):
-Red, tan, purple and orange tattoo ink removal
-Sky blue (light) tattoo ink removal
-Green tattoo tattoo ink removal
-Treatment of benign pigmented lesions including, but not limited to: cafe-au-lait birthmarks, solar lentigines, senile lentigines, senile lentigines, Becker's nevi, freckles, common nevi, nevus spilus
-Treatment of benign vascular lesion including, but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi
-Seborrheic Keratosis
-Treatment of post-inflammatory hyperpigmentation
-Skin resurfacing procedures for the treatment of acne scars and wrinkles
-Removal of epidermal pigmented lesions
532 nm wavelength in long pulse mode:
-Incision, ablation vaporization, coagulation and hemostasis of vascular lesions and soft tissue in various surgical areas. All soft tissue is included, such as skin, cutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands.
-The treatment (hemostasis, color lightening, blanching, reduction of lesion size) of the benign vascular lesions (Angiomas, Hemangiomas, Telangiectasia)
532 nm wavelength in PICO mode:
-Tattoo removal in Skin Types I - III
-Treatment of benign pigmented lesions in Fitzpatrick Skin Types I-IV
The Fotona StarWalker Laser System Family is based on the previously cleared Fotona StarWalker Laser System Family (K171227).The device is based on the Nd:YAG (1064 nm) and frequency doubled KTP Nd:YAG (532 nm) laser technology. There is one optical cavity containing the Nd:YAG crystal. The frequency doubled KTP Nd:YAG wavelength is achieved by directing the Nd:YAG laser beam through a frequency doubling non-linear crystal. The Nd: Y AG laser is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming beams are guided by articulated arm to a focusing variable spot handpiece. Optionally, the KTP Nd:YAG beam can be guided to a 585nm dye converter handpiece, or to a 650nm dye laser converter handpiece. The dye handpieces convert the KTP 532 nm wavelength beam into a 585 nm or a 650 nm wavelength, correspondingly. The user activates laser emission by means of a footswitch. All handpieces are equipped with sensors for automatic detection of a handpiece type and the spot size.
The provided text is a 510(k) premarket notification for a medical device, specifically a laser system. It details the device's indications for use, technological characteristics, and comparison to predicate devices, along with the non-clinical tests performed.
However, the document states "Clinical Summary: Not Applicable." This means that no clinical studies were performed, and therefore, there is no information regarding acceptance criteria for device performance based on human reader studies, an AI algorithm's standalone performance, ground truth establishment, or sample sizes related to clinical data.
The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons and adherence to relevant safety and performance standards (EN, IEC, ISO).
Therefore, I cannot provide the requested information, particularly points 1 through 9, as they pertain to clinical studies that were explicitly stated as "Not Applicable" in this submission.
§ 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.