FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BQ/BM INTEGRATED LASER DELIVERY SYSTEM
K Number: K990665
·
Decision May 17, 1999
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
5
Review Days
76
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Basic Information
- Device Name
- BQ/BM INTEGRATED LASER DELIVERY SYSTEM
- K Number
- K990665
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- American Laser Corp.
- Date Received
- March 2, 1999
- Decision Date
- May 17, 1999
- Product Code
- HQF
- 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 |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
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Other Clearances by American Laser Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K010046 | NUVOLASE 532 MEDICAL LASER SYSTEM | Apr 5, 2001 | Substantially Equivalent |
| K990725 | NUVOLASE 532 LASER SYSTEM | Mar 22, 1999 | Substantially Equivalent |
| K827819 | LASER PHOTOCOAGULATOR | Jan 7, 1983 | Substantially Equivalent |
| K813429 | LASER PHOTOCOAGULATOR ARGON MED. LASER | Jan 22, 1982 | Substantially Equivalent |