510(k) intended use statements: diodes

Below is a list of diode lasers cleared by FDA. The intended use of each is quoted verbatim from FDA clearances, followed by the date the clearance was issued. Some devices have more than one intended use, because they submitted for additional clearance.

[Name] -- indicates alternate device or manufacturer names

(K123456) -- indicates 510(k) number for each submission

-

Coherent Star LightSheer [StarLight]

(K973324) "The StarLight Pulsed Diode Array Laser System is intended to remove hair in Dermatology and Plastic Surgery procedures." 12/3/97

(K982940) "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." 4/8/99

IRIDEX [Iriderm] Apex 800

(K992298) "The Iriderm Apex 800 is indicated for hair removal." 12/09/99

Nidek EpiStar

(K990119) "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." 2/27/00

Palomar Super Long Pulse, SLP™ 1000, diode

(K994225) “The Palomar Super Long Pulse, SLP™ 1000, diode laser system is indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands, and specifically for the following indications.

Dermatology and Plastic Surgery for:

Hair Removal in Skin Types I-VI

Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions.

Photothermolysis of blood vessels (treatment of facial and leg veins)

Removal of pigmented lesions

Photothermolysis" 5/18/00

Aesclepion [Aesculap-Meditec] MeDioStar

(K994116) "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." 06/01/00

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

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