CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE
FDA 510(k) clearance K864610 · decided 1987-06-18
Clearance details
- K-number
- K864610
- Device name
- CILAS YM 101 ND:YAG LASER FOR NEUROLOGICAL USE
- Applicant
- Inframed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-20
- Decision date
- 1987-06-18
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- LLF
- Device class
- 3
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Needham, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ENDOCOAGULATOR MODELS 5, 8 & 20 ARGON LASER (K870773) | Hgm, Inc. | 1987-07-10 |
| MODEL 545-45 FOR NEUROLOGICAL SURGICAL APPLICATION (K860977) | Britt Corp., Inc. | 1986-10-16 |
| COOPER MEDICAL MODEL 770 (K833497) | Cooper Medical Corp. | 1984-04-17 |
Recalls involving this device
No recalls on record reference this clearance.