Manufacturer
Amd Group, LLCPicasso Plus, Picasso Lite Plus
Country / Region:United States (US)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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
2Cited as predicate
2SkyPulse
Picasso Pro Diode Laser (002-00460)
2 submissions cite K152939 as a predicate