FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIS
K Number: K923543
·
Decision Mar 29, 1993
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
46
Applicant Total
30
Review Days
256
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Basic Information
- Device Name
- MIS
- K Number
- K923543
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.1570
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ceram Optec, Inc.
- Date Received
- July 16, 1992
- Decision Date
- March 29, 1993
- Product Code
- HLJ
- 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 |
|---|---|---|---|
| HLJ | Ophthalmoscope, Battery-Powered | FDA class 2 | Ophthalmic |
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Other Clearances by Ceram Optec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K002296 | CERALAS G15 532NM FREQUENCY DOUBLED ND:YAG LASER, MODEL G1-G15 | Oct 2, 2000 | Substantially Equivalent |
| K001975 | CERALAS D10 810NM LASER, MODEL CERALAS D10-60 | Aug 4, 2000 | Substantially Equivalent |
| K993911 | CERALAS D DIODE LASER SYSTEM, MODEL D15, D25,D50 | Feb 1, 2000 | Substantially Equivalent |
| K993828 | CERALAS D10 810NM DIODE LASER | Feb 1, 2000 | Substantially Equivalent |
| K993002 | CERALAS D 980NM DIODE LASER SYSTEM, MODEL D15 | Oct 14, 1999 | Substantially Equivalent |
| K992773 | CERALAS D10 810NM DIODE LASER | Sep 1, 1999 | Substantially Equivalent |
| K991891 | CERALAS DIODE LASER SYSTEM, MODEL CERALAS D15 | Jun 24, 1999 | Substantially Equivalent |
| K983950 | CERALAS DIODE LASER SYSTEM (MODEL H) | Feb 3, 1999 | Substantially Equivalent |
| K983058 | CERALAS D LASER SYSTEM, MODEL # CERALAS D15 | Oct 21, 1998 | Substantially Equivalent |
| K980389 | MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES | Jul 29, 1998 | Substantially Equivalent |