FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
Pollogen Legend+ System
K Number: K171359
·
Decision Sep 13, 2017
Classifications
1
FEI Numbers
823
Registration Numbers
823
Same Product Code
2306
Applicant Total
18
Review Days
127
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Pollogen Legend+ System
- K Number
- K171359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4400
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pollogen, Ltd.
- Date Received
- May 9, 2017
- Decision Date
- September 13, 2017
- Product Code
- GEI
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEI), ordered by most recent decision date.
Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coating
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
CoolSeal Generator® (CSL-200-90)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROMARK System (NMK00301)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LAP-iX2N
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
OsteoCool RF Ablation System; OsteoCool 2.0 RF Ablation System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MILAN System
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Pollogen, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K242227 | GENEO X ELITE | Oct 12, 2025 | Substantially Equivalent |
| K252576 | Legend X Platform | Sep 12, 2025 | Substantially Equivalent |
| K250734 | OptiLUV Device | Sep 10, 2025 | Substantially Equivalent |
| K243217 | Legend X Desktop System | Nov 1, 2024 | Substantially Equivalent |
| K240999 | Legend X Applicator VO | May 8, 2024 | Substantially Equivalent |
| K233766 | Geneo X Elite | May 7, 2024 | Substantially Equivalent |
| K232903 | Legend X Platform | Oct 17, 2023 | Substantially Equivalent |
| K220322 | Pollogen STOP U Model UXV Device | May 4, 2023 | Substantially Equivalent |
| K220124 | YandR System, VoluDerm Handpiece, VoluDerm Tips | Feb 17, 2022 | Substantially Equivalent |
| K200545 | Legend Pro DMA | Oct 21, 2021 | Substantially Equivalent |