Identity
- Trade Name
- Spot-On 2 LED Headlight FDA UDI
- Generic Name
- General-purpose light source FDA UDI
- Device Name
- Illuminate the oral cavity without blinding your patient. Spring clip mount fits most eyewear. Loupe mount also included. Continuously adjustable spot size, from 0.6" dia. to 3" dia. at a working distance of 14". XY-adjustable light mount directs illumination exactly where you need it. Eight brightness levels to suit varying lighting needs. Long-lasting LED bulb provides crisp, white light. Sharp, circular focus eliminates perimeter "halos." Weighs only 0.8 oz. (without cord or battery). Specifications: Operating time: 2-1/2 hours on one six-hour charge. Spot diameter: 0.6"-3" at 14" working distance. Lamp weight: 0.8 oz. (without cord or battery). Light intensity: adjustable up to 23,000 lux. Color temp.: 6,000K (±1,000). Battery: 2,600mAh rechargeable Lithium. System includes 5V charger, spring clip mount, loupe mount, two battery packs, clip-on leather battery case, cord clips, and padded storage case. One year warranty. FDA UDI
- Model / Reference
- 08264B FDA UDI
- Description
- Illuminate the oral cavity without blinding your patient. Spring clip mount fits most eyewear. Loupe mount also included. Continuously adjustable spot size, from 0.6" dia. to 3" dia. at a working distance of 14". XY-adjustable light mount directs illumination exactly where you need it. Eight brightness levels to suit varying lighting needs. Long-lasting LED bulb provides crisp, white light. Sharp, circular focus eliminates perimeter "halos." Weighs only 0.8 oz. (without cord or battery). Specifications: Operating time: 2-1/2 hours on one six-hour charge. Spot diameter: 0.6"-3" at 14" working distance. Lamp weight: 0.8 oz. (without cord or battery). Light intensity: adjustable up to 23,000 lux. Color temp.: 6,000K (±1,000). Battery: 2,600mAh rechargeable Lithium. System includes 5V charger, spring clip mount, loupe mount, two battery packs, clip-on leather battery case, cord clips, and padded storage case. One year warranty. FDA UDI
Identifiers
- Catalog Number
- 71-31112 FDA UDI
- Primary DI / UDI-DI
- 00723896008645 FDA UDI
- FDA Product Code
- HPP FDA UDI
- GMDN Term
- General-purpose light source FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 886.4335 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: General-purpose light source
Spot-On 2 LED Headlight by Practicon, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Practicon, Inc.
Sources (1)
- FDA UDI 309825d8-4ad6-4020-ac8a-3c78fc60cfb4 34 fields · synced Jun 8, 2026