Manufacturer
Active Optical Systems , Ltd.Spirit Hair Removal laser Family
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K153718
- Device name
- Spirit Hair Removal laser Family
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2015-12-28
- Decision date
- 2016-02-12
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
The Spirit Hair Removal laser Family is generally intended for dermatological use. The devices are specifically indicated for hair removal, permanent hair reduction by using selective laser energy. The Spirit Hair Removal laser Family is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent reduction in hair regrowth is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Intended Use
The Spirit Hair Removal laser Family is generally intended for dermatological use. The devices are specifically indicated for hair removal, permanent hair reduction by using selective laser energy. The Spirit Hair Removal laser Family is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin. Permanent reduction in hair regrowth is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Device Description
The Spirit Hair Removal laser Family has two models of the same device (916, & 918) and several trade names. The devices apply photothermal energy to human skin tissue to effect a desired change in the structure of the tissue. The energy is transmitted from a 810nm laser diode to the target tissue by a Treatment Handpiece that is in contact with the skin. The 918 and 916 models have fully identical HW. The difference in the optical output power (6 -90J/cm2 for the 918 model and 4.5 to 10J/cm2 for the 916 model) is preset. For the hair removal treatment, the devices utilized laser energy at the spectrum of 810nm (IR) which is absorbed by the Melanin which is located in the hair follicles. Once the energy is absorbed, it is turned into heat. The heat coagulates the hair follicles and removes the unwanted hair. The Spirit Hair Removal laser Family was designed to comply with international standards and is constructed from metal, plastic a diode laser and other electronic components.
Summary parsed at:2026-06-01 06:05:36 UTC
Predicate devices
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Not ingested
K153718 references 1 predicate/reference device
Cited as predicate
3Diode Laser System
Medical Diode Laser Hair Removal System
Darwin
3 submissions cite K153718 as a predicate
