Below is a list of ruby 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.
ESC/Sharplan EpiTouch
(K962446) No FDA signoff attached. Submission states:
It is intended for use in dermatology for the removal of unwanted
dark body hair. 03/07/97
(K972099) “The Sharplan Ruby Laser
System, with its fiber delivery system, is intended for use
in dermatology for the removal of unwanted body hair."
8/27/97
Mehl/Biophile [Classy
Lady by Mehl] Chromos 694 [QD], [Ruby Laser, Mark I]
(K962109) No FDA signoff attached. Submission states:
selective photothermolysis for depilation. 03/13/97
(K971814) “The Chromos 694 (MEHL) Ruby
Laser, Mark I, is indicated for the removal of unwanted body
and facial hair." 08/01/97
(K980753) Scanner "To be used with
the MEHL Chromos 694 Ruby Laser for the removal of unwanted
body and facial hair." 06/29/98
Polytec PI LaseAway
ruby
(K971193) “The LaseAway Long Pulse
and Q-switched ruby laser system is intended to remove blue/black
tattoos and benign dermal and epidermal pigmented lesions,
and, to effect hair removal of patients with skin types 1-4
through selective targeting of melanin in hair follicles in
dermatology and plastic surgery." 06/24/97
Medical Laser Technologies
MLT R694
(K980187) “The MLT R694 Ruby Laser
System is intended to remove unwanted body hair. Patient selection
criteria include patients with skin types 1-4."
04/03/98
Palomar [Spectrum]
EpiLaser
(K963947) “The EpiLaser Normal Mode
Ruby Laser is intended to effect hair removal of patients
with skin types 1 – 4 through selective photothermolysis
of hair follicles in dermatology and plastic surgery. This
results in a prolonged growth delay." 03/05/97
(K980160) “NOTE: The following indications
for use are quoted from the Indications for Use statement
for the EpiLaserü as described in K963947 (the laser has been
renamed the EpiLaser I). The indications for use in this APPENDIX
are provided for the record; the installation of the upgrade
kit does not affect or alter these indications. The upgrade
kit itself does not have indications for use. The EpiLaser
I is intended to effect hair removal of patients with skin
types 1 – 4 through selective targeting of melanin in
hair follicles in dermatology and plastic surgery. The EpiLaser I was limited to prescription
use at the time of the substantially equivalent decision.
(March 5, 1997).”
(K980517) “The EpiLaser is intended
to effect temporary hair reduction in skin types I-IV. The
EpiLaser 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 long-term stable reduction in the number of hairs
regrowing after a treatment regime." 07/21/98
Palomar LightSheer
Ruby
(K980429) “The LightSheer is intended
to effect hair removal of patients with skin types 1 –
4 through selective targeting of melanin in hair follicles.
Note: The EpiLaser was limited to prescription use at the
time of the substantially equivalent decision. (March 5, 1997).
Palomar Medical Technologies, Inc. proposes that the LightSheer
be a limited to prescription use also."
05/04/98
(K982980) “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." 03/04/99
Aesclepion [Aesculap-Meditec]
RubyStar
(K991285) “The laser system Ruby Star
(operating in normal use) is intended to remove unwanted body
hair. The laser system Ruby Star (operating in Q-Switch mode)
is indicated for cutting, vaporization, or ablation of soft
tissue. This includes tattoo removal and treatment of benign
pigmented lesions. Some examples of benign pigmented lesions
are: Lentigines, CafÑ-au-lait-blotches, Ephalides, Benign
Naevi such as Nevus of Ota, Naevus of Ito, Epidermal naevi,
Congenital naevi, Becker's naevi, Blue naevus, Naevus spilus,
and Mongolian spot. The laser system Ruby Star is restricted
to sale or use by licensed professionals in the United States"
07/12/99
