ACULUX, MODEL AX3001, AX3002
FDA 510(k) clearance K001223 · decided 2000-06-23
Clearance details
- K-number
- K001223
- Device name
- ACULUX, MODEL AX3001, AX3002
- Applicant
- Aculux
- Decision
- Substantially Equivalent
- Date received
- 2000-04-17
- Decision date
- 2000-06-23
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- FQP
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Naples, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Aculux
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SYNTHES LIGHT GUIDE (K993314) | Synthes (Usa) | 1999-12-06 |
| SURGICAL LIGHT 22 SERIES (K781581) | American Sterilizer Co. | 1978-10-17 |
| HANDLES, LIGHT, SURGICAL, STEOILE (K770812) | Sybron Corp. | 1977-05-23 |
| SURGICAL LIGHT - CHALLENGE 22 SERIES (K761018) | Amsco Co. | 1977-01-26 |
Recalls involving this device
No recalls on record reference this clearance.