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Fraxis Duo Main Unit
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref FRAXIS
by CLASSYS Inc.
Identity
- Trade Name
- FRAXIS EUDAMEDFraxis Duo Main Unit FDA UDIFraxis Set Package FDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Device Name
- CO2 laser system EUDAMED
- Model / Reference
- FRAXIS EUDAMEDFRX-C2 FDA UDIFRX-C1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800016903959 EUDAMEDFDA UDI08800016903638 FDA UDI
- Basic UDI-DI
- B-08800016903959 EUDAMED
- FDA Product Code
- GEI FDA UDIGEX FDA UDIOUH FDA UDIONG FDA UDI
- EMDN Code
- Z12011005 CARBON DIOXIDE SURGICAL LASER EUDAMED
- GMDN Term
- Dermatological carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI878.4810 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatological carbon dioxide laser system
Fraxis Duo Main Unit by CLASSYS Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dermatological carbon dioxide laser system.
- MedArt Intenz — Medart A/S · Class II
- DEKA SMART US-20D — EL.EN. SPA · Class II
- 5-Pk, external hygienic, CO2RE Intima — Candela Corporation · Class II
- DEKA SMARTXIDE TOUCH — EL.EN. SPA · Class II
- Fraxis Duo ARM — ILOODA.CO., LTD · Class II
- Edge Arm — Jeisys Medical Inc. · Class II
- Standard Hand-piece packing Assy, CO2RE — Candela Corporation · Class II
- DEKA SMARTXIDE 50 — EL.EN. SPA · Class II
Cleared under the same submission
K160312 also covers:
- Fraxis DUO Set Package — CLASSYS Inc.
- Fraxis Duo 25Pin Needle Tip — CLASSYS Inc.
- Fraxis Duo Articulated arm — CLASSYS Inc.
- Fraxis Duo Needle Handpiece — CLASSYS Inc.
- Fraxis Duo Scanner Handpiece — CLASSYS Inc.
- Fraxis Duo 25Pin Needle Tip — ILOODA.CO., LTD
- Fraxis Duo ARM — ILOODA.CO., LTD
- Fraxis Duo Main Unit — ILOODA.CO., LTD
- Fraxis Duo Needle H/P — ILOODA.CO., LTD
- Fraxis Duo Scanner H/P — ILOODA.CO., LTD
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- CLASSYS Inc.
Sources (3)
- FDA UDI 14e1cb80-0e1f-45bb-bf37-d13b2f020eda 33 fields · synced Jul 8, 2026
- FDA UDI 5aebde46-4cc4-4203-821d-c6219cc89298 33 fields · synced May 30, 2026
- EUDAMED 64e81be5-c215-4b71-adea-01ede5c2c93e 61 fields · synced Jul 8, 2026