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Picasso Plus, Picasso Lite Plus

Amd Group, LLC

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

Product code GEX· 21 CFR 878.4810

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Company

Amd Group, LLC
United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

2
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Device details

FDA 510(k) registration fields

K number
K152939
Device name
Picasso Plus, Picasso Lite Plus
Company
Amd Group, LLC
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2015-10-05
Decision date
2015-11-25
Submission type
Special
Technology type
Diode(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Picasso line of soft tissue dental lasers is designed for a wide variety of oral soft tissue surgical, non-surgical, and teeth whitening procedures.

Intended Use

The Picasso line of soft tissue dental lasers is designed for a wide variety of oral soft tissue surgical, non-surgical, and teeth whitening procedures.

Device Description

The Picasso Plus and Picasso Lite Plus lasers employ semiconductor diodes as a laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The laser delivery used may be in the form of strippable fiber or a multi-tip handpiece that is used in conjunction with disposable tips. The device is activated by means of a wireless footswitch.

Summary parsed at:2026-06-01 06:11:49 UTC

Predicate devices

2

K152939 references 2 predicate/reference devices

Cited as predicate

2

2 submissions cite K152939 as a predicate