FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTOSCALPEL I LASER SYSTEM
K Number: K923531
·
Decision Nov 12, 1993
Classifications
1
FEI Numbers
26
Registration Numbers
27
Same Product Code
29
Applicant Total
2
Review Days
484
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Basic Information
- Device Name
- OPTOSCALPEL I LASER SYSTEM
- K Number
- K923531
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4690
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Optomed Corp.
- Date Received
- July 16, 1992
- Decision Date
- November 12, 1993
- Product Code
- HQB
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HQB | Photocoagulator And Accessories | FDA class 2 | Ophthalmic |
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Other Clearances by Optomed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K990417 | DERMACOOL | Apr 14, 1999 | Substantially Equivalent |