FDA 510(k) Intended use statements: ruby lasers

510(k) intended use statements: ruby lasers

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.

[Name] — indicates alternate device or manufacturer names

(K123456) — indicates 510(k) number for each submission

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 EpiLaser

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