FDA 510(k) diode laser intended use

FDA 510(k) diode laser intended use statements

Below is a list of diode lasers cleared by FDA. The intended use of each is quoted verbatim from FDA clearances.

Intended use

Coherent Star LightSheer [StarLight]

"The StarLight Pulsed Diode Array Laser System is intended to remove hair in Dermatology and Plastic Surgery procedures."

501(k)#: K973324 Cleared: 12/3/97 SE device: EpiLaser K963947 New data: yes

Coherent Star LightSheer

"The LightSheer is intended to effect temporary hair reduction in skin types I-IV. The LightSheer is also intended to effect stable long-term, or permanent, hair reduction in skin types I-IV through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs regrowing after a treatment regime."

501(k)#: K982940 Cleared: 4/8/99 SE device: LightSheer 973324 New data: yes

IRIDEX [Iriderm] Apex 800

"The Iriderm Apex 800 is indicated for hair removal."

501(k)#: K992298 Cleared: 12/09/99 SE device: PhotoGenica K971737 LightSheer K973324 New data: none

Nidek EpiStar

"The Epi-Star Surgical Laser System is intended to be used for Plastic Surgery and Dermatology, with the intended uses for the treatment of vascular and pigmented lesions in dermatology, and for the removal of hair."

501(k)#: K990119 Cleared: 2/27/00 SE device: nidek diolight 60 for lesions (=photogenica) K981447, lightsheer K980420 EpiTouch Alex K973354, GentleLASE K981351, PhotoGenica K971737 New data: none Notes: also Nidek lesion 980201

Aesclepion [Aesculap-Meditec] MeDioStar

"The laser system MeDioStar H (with and without skin cooling) is intended to remove unwanted body hair and vascular lesions. The laser system MeDioStar H is restricted to sale or use by licensed professionals in the United States."

501(k)#: K994116 Cleared: 06/01/00 SE device: LightSheer K982940; Lyra K990903; GentleLASE II K984601 New data: none Notes: sent to william kelley 2525 McGaw Avenue Irvine, CA 92623

 

Source: Releasable 510(k) Database (type in specific 510(k) number to verify intended use)

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