FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BRITT KRYPTON LASERS 150K & 152K
K Number: K813492
·
Decision Jan 22, 1982
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
17
Review Days
42
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Basic Information
- Device Name
- BRITT KRYPTON LASERS 150K & 152K
- K Number
- K813492
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Britt Corp., Inc.
- Date Received
- December 11, 1981
- Decision Date
- January 22, 1982
- 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 Britt Corp., Inc.
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|---|---|---|---|
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| K974393 | VASO PRESS SYSTEM | Mar 19, 1999 | Substantially Equivalent |
| K860977 | MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION | Oct 16, 1986 | Substantially Equivalent |
| K860975 | MODEL 545-45 LASER FOR EAR, NOSE & THROAT | Jul 18, 1986 | Substantially Equivalent |
| K860974 | MODEL 545-45 LASER FOR DERMA., POD., SURGICAL | Jul 7, 1986 | Substantially Equivalent |
| K860277 | MODEL 525-25 WATT C02 LASER FOR EAR, NOSE & THROAT | May 6, 1986 | Substantially Equivalent |
| K860273 | MODEL 525 - 25 WATT CO2 MEDICAL LASER/PODIATRY | Apr 23, 1986 | Substantially Equivalent |
| K860278 | MODEL 525-25 WATT CO2 LASER FOR DERMA/PLASTIC | Apr 15, 1986 | Substantially Equivalent |
| K851425 | MODEL J25-25 WATT CO2 LASER | Nov 12, 1985 | Substantially Equivalent |