Olive Plus

Ama Network, Inc.

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K161981
Device name
Olive Plus
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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