FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
HERACURE LS 500
K Number: K875078
·
Decision Feb 22, 1988
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
47
Applicant Total
2
Review Days
55
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
- HERACURE LS 500
- K Number
- K875078
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.4550
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- W.C. Heraeus GmbH
- Date Received
- December 29, 1987
- Decision Date
- February 22, 1988
- Product Code
- HHR
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HHR | Laser, Surgical, Gynecologic | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HHR), ordered by most recent decision date.
ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MODEL 5050 SURGILASER FOR OB-GYN USE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
GL-35 COLPOSCOPIC LASER SYSTEM
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LASER CANNISTER FILTER
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
Other Clearances by W.C. Heraeus GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K895715 | HANAULUX(R) 2000 | Oct 13, 1989 | Substantially Equivalent |