Document Overview
Document Overview This document is an Initial Product Report Acknowledgment issued by the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Document Mail Center – WO66-G609, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002. The submission was filed pursuant to…
- Document type
- Certification Report
- Prepared by
- Michelle Torres
- Published
- Last reviewed
- Topics
- Lighting Gear
Document Overview
This document is an Initial Product Report Acknowledgment issued by the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Document Mail Center – WO66-G609, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002.
The submission was filed pursuant to the Radiation Control for Health and Safety Act of 1968, governed under Title 21, Code of Federal Regulations (CFR), Subchapter J, specifically reporting requirements under 21 CFR Part 1002.
- Document Type: Initial Product Report Acknowledgment
- Issuing Body: FDA, Center for Devices and Radiological Health (CDRH), Division of Radiological Health
- Date Loaded: March 25, 2026
- Document Date: March 25, 2026
- Accession Number: 2610611-000
- Scope: Surveying, Leveling, and Alignment Laser Products — electronic radiation-emitting devices subject to FDA radiation safety performance standards
Important Notice: The accession number is solely an acknowledgment of receipt by FDA. It does not imply, convey, or constitute FDA approval of the submission or its contents, and may be revoked by FDA.
Product Information
The registered product is the ETENWOLF L2, a surveying, leveling, and alignment laser device classified under the FDA CDRH product category.
- Product Model: L2
- Product Category: Surveying, Leveling, Alignment Laser Products
- CDRH Product Code: RES — defined as Laser Pointer
- FDA Product Entry Code (for U.S. shipments): 95R- -ES
- Establishment Name: GUANGDONG BESTEK TECHNOLOGY CO., LTD.
- Reporting Official: Jie Xiao ([email protected])
- Submitter: Simon Chen, SGS ([email protected])
The ETENWOLF L2 is designed for professional and consumer-grade leveling, surveying, and alignment applications, emitting laser radiation subject to federal radiation control regulations.
Key Details
The table below summarizes the key submission data as recorded in the FDA CeSub Submission Process acknowledgment:
| Field | Detail |
|---|---|
| Accession Number | 2610611-000 |
| Date Loaded | March 25, 2026 |
| Document Date | March 25, 2026 |
| Submission Type | Initial Product Report |
| Establishment Name | GUANGDONG BESTEK TECHNOLOGY CO., LTD. |
| Product Model | L2 |
| CDRH Product Code | RES (Laser Pointer) |
| FDA Entry Code | 95R- -ES |
| Submitter | Simon Chen — [email protected] |
| Reporting Official | Jie Xiao — [email protected] |
| Annual Report Deadline | September 1 each year |
Shipping brokers importing the L2 into the United States must provide the full FDA product code 95R- -ES at the time of customs entry.
Standards & Compliance
The ETENWOLF L2 laser level is subject to the following U.S. federal regulations for radiation-emitting electronic products:
- 21 CFR 1002.11 — Report supplements required under certain post-market circumstances
- 21 CFR 1002.13 — Annual reports to CDRH due by September 1 each year
- 21 CFR 1010–1050 — Certification to FDA radiation safety performance standards for electronic products
- 21 CFR 807 — Manufacturer registration and device listing requirements
- 21 CFR 807, 812, and 814 — Medical device clearance or approval requirements where applicable
- 21 CFR Part 1003 — Discovery of Defect or Failure to Comply obligations
- 21 CFR Part 1004 — Repurchase, Repair, or Replacement of Electronic Products
Failure to comply with these regulations may result in mandatory notification of affected persons and corrective actions at no cost to the purchaser.
Validity & Certification Body
This FDA acknowledgment is effective from the date of filing and remains valid subject to annual renewal and continued compliance with applicable CFR requirements.
- Filing Date: March 25, 2026
- Annual Renewal Deadline: September 1 each year (Annual Report to CDRH)
- Issuing Authority: U.S. Food and Drug Administration (FDA)
- Division: Division of Radiological Health, Office of In Vitro Diagnostics and Radiological Health, Center for Devices and Radiological Health (CDRH)
- Address: Document Mail Center – WO66-G609, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002
- Reference Resources:
The accession number 2610611-000 serves as the permanent identifier for this submission and must be referenced in all future correspondence with FDA regarding the L2 product line.
Frequently Asked Questions
- What does the FDA accession number 2610611-000 mean for the ETENWOLF L2?
-
The accession number 2610611-000 confirms that the FDA has received and filed the Initial Product Report for the ETENWOLF L2 laser level. It is an acknowledgment of receipt only — it does not constitute FDA approval of the product. It serves as the official identifier for all future FDA correspondence related to this submission.
- Is the ETENWOLF L2 cleared to be sold and shipped to the United States?
-
Yes. Per the FDA acknowledgment, if all other applicable FDA requirements are met, the ETENWOLF L2 may be marketed in the United States. Shipping brokers must declare the FDA product entry code 95R- -ES at the time of U.S. customs entry.
- What ongoing compliance obligations apply to the ETENWOLF L2 under FDA regulations?
-
GUANGDONG BESTEK TECHNOLOGY CO., LTD. is required to submit an Annual Report to CDRH by September 1 each year under 21 CFR 1002.13. Additional obligations include report supplements (21 CFR 1002.11), radiation safety performance certification (21 CFR 1010–1050), and device listing (21 CFR 807).
- What is the CDRH product code for the ETENWOLF L2, and why does it matter?
-
The CDRH product code assigned to the ETENWOLF L2 is RES, categorized as a Laser Pointer. This code, structured as 95R- -ES for U.S. entry purposes, is required by shipping brokers at customs to correctly classify the product as a radiation-emitting electronic device subject to FDA oversight.
Related Documents
The following certification and compliance documents are relevant to the ETENWOLF L2 laser level and are recommended for a complete regulatory profile:
- FCC Part 15 Certification — Required for radio frequency emissions compliance for electronic devices sold in the U.S. market
- CE Declaration of Conformity — Mandatory for market access in the European Economic Area, covering laser safety (EN 60825-1) and EMC directives
- IEC 60825-1 Laser Safety Test Report — International standard for laser product safety classification and labeling requirements
- RoHS Compliance Certificate — Confirms restriction of hazardous substances in electrical and electronic equipment for EU and global markets
- REACH Declaration — Substance compliance declaration under EU chemical safety regulations
- California Proposition 65 Warning Compliance — Required for products sold in California containing chemicals on the Prop 65 list
- UN 38.3 Battery Transport Test Report — Applicable if the L2 ships with lithium batteries, certifying safe transport compliance
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