FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOLAS YAG 100 CILAS, ERCELAS YAG 100
K Number: K843156
·
Decision Oct 1, 1984
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
59
Applicant Total
4
Review Days
52
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
- BIOLAS YAG 100 CILAS, ERCELAS YAG 100
- K Number
- K843156
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Advanced Biomedical Instruments
- Date Received
- August 10, 1984
- Decision Date
- October 1, 1984
- Product Code
- LNK
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| LNK | Laser For Gastro-Urology Use | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LNK), ordered by most recent decision date.
TECHNOMED PULSOLITH 4000 LASER SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MDL-2000 LASERTRIPTER
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE
FDA 510(k)
FDA Class 2
·General, Plastic Surgery