Identity
- Trade Name
- LightScalpel FDA UDI
- Generic Name
- Dermatological carbon dioxide laser system FDA UDI
- Device Name
- LS-4020, 40W CO2 Laser System FDA UDI
- Model / Reference
- LS-4020 FDA UDI
- Description
- LS-4020, 40W CO2 Laser System FDA UDI
Identifiers
- Catalog Number
- LS9032-01 FDA UDI
- Primary DI / UDI-DI
- 00851842007623 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Dermatological carbon dioxide laser system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Dermatological carbon dioxide laser system
LightScalpel by Lightscalpel Inc — Class II — FDA UDI — listed in FDA GUDID — 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
- Secret PRO Scanner Handpiece — CLASSYS Inc. · Class II
Cleared under the same submission
K123037 also covers:
K132661 also covers:
K141658 also covers:
- LightScalpel — LIGHTSCALPEL INC
- LightScalpel — LIGHTSCALPEL INC
- LightScalpel — LIGHTSCALPEL INC
- LightScalpel — LIGHTSCALPEL INC
- LightScalpel — LIGHTSCALPEL INC
- LightScalpel — LIGHTSCALPEL INC
- LightScalpel — LIGHTSCALPEL INC
- LightScalpel — LIGHTSCALPEL INC
- LightScalpel — LIGHTSCALPEL INC
- LightScalpel — LIGHTSCALPEL INC
- LightScalpel — LIGHTSCALPEL INC
- LightScalpel — LIGHTSCALPEL INC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Lightscalpel Inc
Sources (1)
- FDA UDI eb774a7d-b2e3-460f-b75d-724dc17017a5 37 fields · synced May 31, 2026