510(k) intended use statements: flash lamps Below is a list of flash lamps 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
-
 ESC EpiLight
(K963249) “The EpiLight Hair Removal
System is used for the removal of unwanted hair.”
7/7/97
ESC PhotoDerm
HR
(K974536) “The PhotoDerm HR is used
for the removal of unwanted hair.” 5/20/98
ESC EpiLight
& PhotoDerm HR
(K991935) “EpiLight
EpiLight is used for the removal of unwanted hair. EpiLight
is also intended to effect stable long-term, or permanent
hair reduction in skin types I-V 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.
PhotoDerm HR
PhotoDerm HR is used for the removal of unwanted hair. PhotoDerm
HR is also intended to effect stable long-term, or permanent
hair reduction in skin types I-V 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.” 01/27/00
ESC IPL Device
EpiLight, MultiLight
(K994014) “ESC Intense Pulsed Light
Systems: EpiLight and MultiLight, are used for the removal
of unwanted hair from all skin types.” 02/24/00
Radiancy DeLight™
II HR System
(K992482) “The DeLight™ II HR
System is intended for removal of unwanted body and/or facial
hair in adults. The System is specifically indicated for dermatological
use by physicians and healthcare professionals.”
12/27/99
Source: Releasable 510(k) Database (type in specific
510(k) number to verify intended use)
|
|
|
|
Was this helpful?  Support this site!
Still have questions? Ask them at my free HairTell hair removal forum!
|
