FDA 510(k) Intended use statements: alexandrite lasers

510(k) intended use statements: alexandrite lasers

Below is a list of alexandrite 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

Silver Creek Surgical LaseAway

(K982316) “The LaseAway Alexandrite Laser is intended for the cosmetic removal of unwanted hair on adults (18 years or older). The LaseAway Alexandrite Laser System is intended for use only by qualified physicians trained in the safe operation of the system.”

ESC/Sharplan Model 5000

(K973354) “The Sharplan Model 5000 Alexandrite Laser System is intended for use in dermatology for the removal of unwanted dark body hair.” 12/4/97

Candela GentleLase

(K981351) “The Candela GentleLase GL Dermatology Laser is indicated for the following uses:
1. The Photocoagulation of Dermatological vascular lesions
2. The removal of hair.”
7/13/98

(K984601) “The Candela GentleLase II Dermatology Laser is indicated for the following uses:
1. The photocoagulation of dermatological vascular lesions
2. The removal of hair.
The Candela GentleLase II Dermatology Laser includes an integrated Dynamic Cooling Device, which is indicated for:
1. The reduction of pain.
2. Cooling of skin prior to laser treatment.”
2/4/99

(K994260) “The Candela GentleLASE GL Dermatology Laser is indicated for the following uses:
1. The Photocoagulation of Dermatological vascular lesions.
2. Temporary hair reduction.
Stable long-term, or permanent hair reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term stable in the number of hairs regrowing after a treatment regime. It is also intended for the photocoagulation of dermatological vascular lesions.
1/18/00

Cynosure PhotoGenica LPIR, Apogee-TKS, M2

(K971737) “The PhotoGenica LPIR laser is indicated for hair reduction.”

(K994437) “The Cynosure PhotoGenica SPIR is indicated for coagulation of dermatological vascular lesions. 1/18/00

(K994427) “The M2 Laser is indicated for hair removal and benign vascular lesion removal applications. 1/18/00

(K992757) “The Cynosure Apogee-TKS laser is indicated for vascular lesion removal and stable, long-term, or permanent hair reduction. Permanent hair reduction is defined as long-term, stable reduction in the number of hairs re-growing after a treatment regime. The number of hairs re-growing must be stable over a time greater than the duration of the complete growth cycle of hair follicles, which varies from 4-12 months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treated area. 06/29/00

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

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