Manufacturer
Ama Network, Inc.Olive Plus
Country / Region:United States (US)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K161981
- Device name
- Olive Plus
- Company
- Ama Network, Inc.
- Country / Region
- United States(US)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-07-19
- Decision date
- 2016-10-14
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
Olive Plus Diode Laser device is intended for use in dermatologic and general surgical procedures for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI) including tanned skin. Permanent hair reduction is defined as the long-term, 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
Olive Plus Diode Laser device is intended for use in dermatologic and general surgical procedures for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI) including tanned skin. Permanent hair reduction is defined as the long-term, 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 Olive Plus Diode Laser system is a surgical device intended for use to remove or/and reduce unwanted hair in Dermatologic and General Surgical procedures, emitting 810nm diode laser to the treatment area using Hand Pieces and foot switch. The laser beam penetrates through epidermis into dermis and is absorbed by melanin in hair and hair follicle, producing laser photo thermal effect; conducting the energy from hair section to hair root, raising the temperature of melanin and decomposing it, thus reaching the effect of hair removal. During the treatment, the cooling system will operate to reduce the temperature of the treatment area. Laser specification and other system features are controlled by LCD screen. This device consists of Power supply system, Central Control System, Cooling System, Laser Delivery system and safety features. Hand piece tips are made by ABS plastic which are widely used in the medical field.
Summary parsed at:2026-06-01 06:06:47 UTC
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