Identity
- Trade Name
- ASSY, Smart Sense Handpiece, Lipo Molded, 1040 OD FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- ASSY, Smart Sense Handpiece, Lipo Molded, 1040 OD FDA UDI
- Model / Reference
- 100-7007-740 FDA UDI
- Description
- ASSY, Smart Sense Handpiece, Lipo Molded, 1040 OD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841494100353 FDA UDI
- 510(k) Number
- K091537 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- General/multiple surgical frequency-doubled solid-state 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General/multiple surgical frequency-doubled solid-state laser system
ASSY, Smart Sense Handpiece, Lipo Molded, 1040 OD by Cynosure, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as General/multiple surgical frequency-doubled solid-state laser system.
- GREEN LASER PHOTOCOAGULATOR SYSTEM — Nidek, Inc. · Class II
- GreenLight HPS — AMERICAN MEDICAL SYSTEMS, INC. · Class II
- SPECTRA — Lutronic Corporation · Class II
- Scan attachable delivery unit (30SL/M) — Nidek, Inc. · Class II
- Powered Laser Surgical Instrument－Nice Station Light Based Platform — Beijing Syntech Laser Co., Ltd. · Class II
- Scan attachable delivery unit (SL130) — Nidek, Inc. · Class II
- GreenLight™ Laser System Footswitch — Boston Scientific · Class II
- BIO delivery unit (Keeler) — Nidek, Inc. · Class II
Cleared under the same submission
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
- Cynosure, LLC
Sources (1)
- FDA UDI fec5a0d5-56b6-4feb-aba1-46be24673f94 34 fields · synced May 30, 2026