Manufacturer
Vydence MedicalHandPICO Fractional Laser Handpiece Tip
Country / Region:Brazil (BR)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
- K242534
- Device name
- HandPICO Fractional Laser Handpiece Tip
- Company
- Vydence Medical
- Country / Region
- Brazil(BR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-08-26
- Decision date
- 2024-12-20
- Submission type
- Traditional
- Technology type
- Picosecond(AI inferred)
- Clinical applications
- Pigment treatmentAcne treatment
- Primary application
- Pigment treatment
- Classification source
- AI classified
Indications for Use
The handPICO® Fraction Laser Handpiece Tip, when used with the Etherea-MX and Zye lasers at 1064 nm in picosecond mode, is indicated for: • Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. • Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. • Treatment of acne scars in Fitzpatrick Skin Types II-V. • Treatment of wrinkles in Fitzpatrick Skin Types I-IV.
Intended Use
The handPICO® Fraction Laser Handpiece Tip, when used with the Etherea-MX and Zye lasers at 1064 nm in picosecond mode, is indicated for: • Removal of tattoos on all skin types (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. • Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. • Treatment of acne scars in Fitzpatrick Skin Types II-V. • Treatment of wrinkles in Fitzpatrick Skin Types I-IV.
Device Description
The handPICO® Fractional Laser Handpiece Tip is specifically designed for the ETHEREA MX and ZYE® LASERs manufactured by Vydence Medical Inc. The handPICO Fractional Handpiece Tip is a fractional optical element micro lens array that attaches to the handPICO handpiece, producing 280 microbeams/cm2 and a total of 100 microbeams spaced 600 µm apart.
Summary parsed at:2026-06-01 05:29:23 UTC
Predicate devices
2PicoWay Laser System
Discovery Pico, Discovery Pico Plus, Discovery Pico Derm
K242534 references 2 predicate/reference devices
Cited as predicate
1Vydence Family of Lasers
1 submission cite K242534 as a predicate
