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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