FDA 510(k) Intended use statements: flash lamps

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)

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