FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LASER INDIRECT OPHTHALMOSCOPE (LIO)
K Number: K885196
·
Decision Jan 11, 1989
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
148
Applicant Total
27
Review Days
26
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Basic Information
- Device Name
- LASER INDIRECT OPHTHALMOSCOPE (LIO)
- K Number
- K885196
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4150
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Coherent Medical Group
- Date Received
- December 16, 1988
- Decision Date
- January 11, 1989
- Product Code
- HQE
- 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 |
|---|---|---|---|
| HQE | Instrument, Vitreous Aspiration And Cutting, Ac-Powered | FDA class 2 | Ophthalmic |
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|---|---|---|---|
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| K923575 | COHERENT VERSAPLUSE 2.1 HOLMIUM SURG. LASERS | Sep 29, 1993 | Substantially Equivalent |
| K932468 | NOVUS MULTIWAVELENGTH | Sep 22, 1993 | Substantially Equivalent |
| K930981 | ACCULITE(TM) OTOPROBE | Jul 28, 1993 | Substantially Equivalent |
| K914136 | COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE | Jul 21, 1992 | Substantially Equivalent |
| K914991 | VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS | May 6, 1992 | Substantially Equivalent |
| K913127 | COHERENT NOVUS 3000 ARGON PHOTOCOAGULATOR | Oct 8, 1991 | Substantially Equivalent |
| K910037 | COHERENT HOLMIUM:YAG SURGICAL LASER | Sep 25, 1991 | Substantially Equivalent |