Below is a list of Nd:YAG 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.
ThermoLase
SoftLight
(K950019) [purged, no intended statement or summary]
04/03/95
(K971207) “The SoftLight Q-switched
Nd:YAG laser is indicated for use in combination with the
supplied lotion for skin resurfacing. It is also indicated
for the removal or lightening of unwanted facial or body hair."
05/13/98
(K993209) “The ThermoLase SoftLight
Q-switched Nd:YAG Laser is indicated for use with the beam-shrinking
handpiece for the removal or significant reduction in intensity
of black and/or blue-black tattoos. The laser, without the
beam-shrinking handpiece is also indicated for use in combination
with the ThermoLase supplied topical lotion in removing or
lightening unwanted facial or body hair and for laser skin
resurfacing." 12/23/99
Coherent Star
LightSheer [StarLight]
(K973324) "The StarLight Pulsed Diode
Array Laser System is intended to remove hair in Dermatology
and Plastic Surgery procedures."
Cosmos Athos
(K001704) “The Athos laser is intended
for hair removal (destruction of hair follicles) in all skin
types and for soft tissue applications... [continues]”
Continuum MedLite/MedLite
IV
(K973719) “For the removal or lightening
of unwanted hair in the 1064nm mode only."
12/23/97
(K983054) “For the removal or lightening
of unwanted hair in the 1064nm mode only without adjuvant
preparation using one or two treatments."
02/10/99
Altus [Acme] CoolGlide
[Altus Medical Aesthetic Nd:YAG Laser]
(K991798) “The Altus Medical Aesthetic
Nd:YAG Laser is intended for use in surgical and aesthetic
applications requiring selective photothermolysis of target
chromophores in soft tissue in the medical specialties of
general and plastic surgery for: the removal of unwanted hair
in Fitzpatrick skin types I-V." 03/06/00
Focus Medical
Lorad LT-100
(K992597) “The Lorad LT-100 Laser System
is intended for use:
- Alone or in combination with an adjuvant lotion
for the removal or lightening of unwanted facial or body
hair. One or two treatments may be required for lightening
or removing unwanted hair without the adjuvant lotion;
- In combination with the adjuvant lotion for skin
resurfacing (ablation of epidermal skin layers) in dermatology
and aesthetic surgery;
- dermal pigmented lesions (dermal melanocytosis);
and
- for tattoo removal (dark and blue inks).
The adjuvant lotion is a suspension of carbon powder
in a base of Light Mineral Oil, NF.
The Lorad LT-100 Laser Treatment System will be limited to
use by licensed professionals (as provided in 21 CFR 801.109)."
04/24/00
