510(k) intended use statements: Nd:YAG lasers
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.
[Name] — indicates alternate device or manufacturer names
(K123456) — indicates 510(k) number for each submission
(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."
(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
Source: Releasable 510(k) Database (type in specific 510(k) number to verify intended use)