Identity
- Trade Name
- PALLAS Premium Arm FDA UDI
- Generic Name
- General/multiple surgical frequency-doubled solid-state laser system FDA UDI
- Device Name
- PALLAS Premium Arm FDA UDI
- Model / Reference
- PALLAS Premium Arm FDA UDI
- Description
- PALLAS Premium Arm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800035501778 FDA UDI
- 510(k) Number
- K223588 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: General/multiple surgical frequency-doubled solid-state laser system
PALLAS Premium Arm by Laseroptek Co., Ltd — 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
K223588 also covers:
- PALLAS Premium Body — Laseroptek Co., Ltd
- PALLAS Premium Foot Switch — Laseroptek Co., Ltd
- PALLAS Premium Handpiece - 12 x 12 — Laseroptek Co., Ltd
- PALLAS Premium Handpiece - 15 x 15 — Laseroptek Co., Ltd
- PALLAS Premium Handpiece - 18 x 18 — Laseroptek Co., Ltd
- PALLAS Premium User Manual — Laseroptek Co., Ltd
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
- Laseroptek Co., Ltd
Sources (1)
- FDA UDI 77c8b542-6354-4445-b5b4-899e68697a98 35 fields · synced May 30, 2026